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[verwijderd] 1 februari 2007 08:33

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30+ AIDS Vaccine Clinical Trials in 24 Countries; Research Occurring on Every Continent

IAVI Issues Annual Map of AIDS Vaccine Research Activity Worldwide
NEW YORK, January 31, 2007 — The International AIDS Vaccine Initiative's (IAVI) January 2007 Annual Issue of VAX, an editorially independent bulletin on AIDS vaccine research published by IAVI, reports that 13 new preventive AIDS vaccine trials were initiated in eight countries around the world in 2006. There are now more than 30 trials ongoing in 24 countries, across every continent.

This annual publication provides the only comprehensive listing of all AIDS vaccine clinical trial activity worldwide.

Last year saw the start of the first AIDS vaccine trials in the Russian Federation and Zambia, and three countries in sub-Saharan Africa —Kenya, Uganda, and Tanzania—also initiated new trials. The United States, United Kingdom, Sweden and Peru began new trials in 2006 as well. Many of these trials were sponsored by new research groups, including the Karolinska Institute in Sweden, St. George's University of London and the Moscow Institute of Immunology.

All of the new trials that began last year were either Phase I or Phase I/II trials designed to evaluate the safety and immunogenicity of the candidate vaccines. "Although these new trials are early-stage, they will provide critical information over the coming years that will help drive the field's R&D agenda. We hope to begin to see even more novel vectors, as well as approaches that target neutralizing antibodies in the next few years," said CEO and President of IAVI, Dr. Seth Berkley.

IAVI and its collaborators are currently conducting four ongoing trials in India, Kenya, Rwanda, Uganda, South Africa and the United States. In 2006, IAVI launched a Phase II trial in Uganda and Zambia, part of a multi-site study that also included three sites in South Africa. The South Africa, Uganda and Zambia trial sites are now fully enrolled with data expected later this year.

'Two of the most advanced trials underway in 2007 are from Sanofi-Pasteur and Merck & Co., Inc. Data from Merck’s ongoing Phase IIb test-of-concept trial with its adeno-5 vector vaccine candidate is expected in late 2007 or early 2008 and will provide preliminary information on the efficacy of this type of vaccine candidate. These results will have significant implications for the field's future research and development efforts. The company will also soon be starting an additional Phase IIb trial with the same candidate in South Africa.

The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that 4.3 million people were newly infected with HIV last year—bringing the total number of HIV-infected individuals to 40 million people worldwide. Explosive HIV epidemics also continue in Eastern Europe and Central Asia. Throughout the world, a preventive AIDS vaccine remains one of the greatest hopes for stemming the pandemic.

About IAVI
The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996 and operational in 24 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI's financial and in-kind supporters include the Alfred P. Sloan Foundation, the Bill & Melinda Gates Foundation, The John D. Evans Foundation, The New York Community Trust, The Rockefeller Foundation, The Starr Foundation, The William and Flora Hewlett Foundation; the Governments of Canada, Denmark, Ireland, The Netherlands, Norway, Sweden, the United Kingdom, and the United States, the Basque Autonomous Government as well as the European Union; multilateral organizations such as The World Bank; corporate donors including BD (Becton, Dickinson & Co.), Continental Airlines, Google Inc., Merck & Co., Inc. and Pfizer Inc; leading AIDS charities such as Broadway Cares/Equity Fights AIDS and Until There's A Cure Foundation; other private donors such as The Haas Trusts; and many generous individuals from around the world.
iavi.org/

[verwijderd] 1 februari 2007 08:35

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VAX 5 (1), January 2007
SPECIAL ISSUE — 2006: YEAR IN REVIEW
This Special Issue of VAX provides a review of AIDS vaccine clinical trial activity in 2006 and a comprehensive listing of all ongoing trials as of January 2007. Last year 13 new trials of preventive AIDS vaccine candidates started in 8 countries around the world. All were either Phase I or Phase I/II trials designed to evaluate the safety and immunogenicity of the candidate vaccines. The Russian Federation began its first AIDS vaccine trial and three countries in sub-Saharan Africa—Kenya, Uganda, and Tanzania—initiated new trials. The map on the inside pages of this issue focuses on these trials as well as countries that started trials in 2003-2005 that are still ongoing. The accompanying table provides information on all ongoing preventive AIDS vaccine trials

The Joint United Nations Programme on HIV/AIDS (UNAIDS)
estimates that 4.3 million people were newly infected
with HIV last year, the majority (2.8 million) in
sub-Saharan Africa. This brings the total number of HIV-infected
people to 40 million worldwide. A preventive AIDS
vaccine remains the greatest hope for reversing the pandemic’s
relentless spread, and clinical trials of vaccine candidates
are now ongoing on every continent. The world is
responding but more still needs to be done.
This Special Issue of VAX provides a review of AIDS vaccine
clinical trial activity in 2006 and a comprehensive listing of all
ongoing trials as of January 2007. Last year 13 new trials of
preventive AIDS vaccine candidates started in 8 countries
around the world. All were either Phase I or Phase I/II trials
designed to evaluate the safety and immunogenicity of the
candidate vaccines. The Russian Federation began its first
AIDS vaccine trial and three countries in sub-Saharan Africa—
Kenya, Uganda, and Tanzania—initiated new trials. The map
on the inside pages of this issue focuses on these trials as well
as countries that started trials in 2003-2005 that are still ongoing.
The accompanying table provides information on all ongoing
preventive AIDS vaccine trials. For more information,
visit www.iavireport.org/trialsdb. Please email any additions,
comments, or updates to iavireport@iavi.org.

January 2007 • Vol.5 • No.1
AIDS VACCINE BULLETIN WWW.IAVIREPORT.ORG
AN IAVI REPORT PUBLICATION
[ The publication on international AIDS vaccine research ]

YEAR IN
REVIEW
AIDS VACCINE TRIALS
See inside for world map of trials launched in 2006

www.iavireport.org/vax/english/VAX_Ja...

www.iavireport.org/Vax/VAX_Jan07_Map.pdf

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[verwijderd] 2 februari 2007 09:42

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The vaccine candidate, known as the MRKAd5 HIV-1 gag/pol/nef, or trivalent, vaccine, is based on adenovirus, a common cold virus that has been modified so that it cannot reproduce and cause a cold in humans. The adenovirus is used as a vector, or a delivery vehicle, to transport three synthetically produced HIV genes--gag, pol and nef--into cells. These genes stimulate the body to generate a potent cellular immune response to HIV, producing an army of killer T cells programmed to recognize and kill HIV-infected cells. No live HIV is used in the production of the vaccine candidate, so the vaccine candidate cannot cause HIV infection or AIDS.
********************

09 January 2007

HIV Vaccine Study Nears Enrollment Limit at Emory's Hope Clinic

The Hope Clinic of the Emory Vaccine Center today announced that the Step Study, a multicenter international study of an HIV vaccine developed by Merck and Co., Inc., has successfully enrolled more than 2,800 people and expects to finalize enrollment within the next few months.
Cosponsored by the HIV Vaccine Trials Network (HVTN), the study plans to fill 200 slots at the participating sites in North and South America, the Caribbean and Australia.
"We have been very pleased with the depth of support for the Step Study that we have seen in Atlanta," says Carlos del Rio, MD, principal investigator for the Step Study at Emory. "Our community is well aware of the need for a vaccine against HIV and has demonstrated its commitment by stepping forward to volunteer for the study."
The study has enrolled volunteers who are HIV negative and generally healthy, but who have certain risk factors for HIV. The vaccine candidate used in this study has generated strong and durable cellular immune responses against HIV in early human trials.
According to UNAIDS, nearly 46 million people were living with HIV in 2006. With more than 11,000 new HIV infections each day, 95 percent of which occur in developing countries, the global epidemic shows no sign of abating. UNAIDS has reported that a record 2.9 million people died of AIDS in 2006.
As with other infectious diseases, development of a vaccine is recognized as the best long-term hope to end the AIDS pandemic. Vaccines are a critical part of an integrated strategy to fight HIV infection, which also includes treatment and prevention.
Study Details
The Step Study is a collaboration of Merck & Co., Inc., the HVTN, and the National Institute of Allergy and Infectious Diseases (NIAID), which funds and supports the HVTN. It combines Merck's vaccine research efforts and clinical trials expertise with the clinical trials experience and global capacity of the HVTN.
The study is a multicenter, randomized, double-blind, placebo-controlled Phase II trial of about 3,000 male and female volunteers ages 18 to 45 of diverse racial groups who are at high risk for contracting HIV. All study participants have received counseling about how to reduce their risk of HIV infection.
The vaccine candidate, known as the MRKAd5 HIV-1 gag/pol/nef, or trivalent, vaccine, is based on adenovirus, a common cold virus that has been modified so that it cannot reproduce and cause a cold in humans. The adenovirus is used as a vector, or a delivery vehicle, to transport three synthetically produced HIV genes--gag, pol and nef--into cells. These genes stimulate the body to generate a potent cellular immune response to HIV, producing an army of killer T cells programmed to recognize and kill HIV-infected cells. No live HIV is used in the production of the vaccine candidate, so the vaccine candidate cannot cause HIV infection or AIDS. About The Hope Clinic of the Emory Vaccine Center
The Hope Clinic, located in downtown Decatur near the Emory University campus, was created in 2002 to conduct clinical trials of promising new vaccines and therapeutic interventions for challenging infectious diseases. The Emory Vaccine Center, part of the Yerkes National Primate Research Center and Emory University School of Medicine, was established in 1997 and is home to one of the nation's largest and most respected basic and preclinical vaccine research programs. The Hope Clinic has become one of the leading clinical vaccine trial sites in the country.
About the HIV Vaccine Trials Network
The HVTN is an international collaboration of scientists and institutions whose goal is to accelerate the search for an HIV vaccine by sharing trial results and facilitating parallel, concurrent testing. The HVTN is a unique hybrid that combines the depth and diversity of the academic community and the flexibility of a commercial drug company.
Working with industry and government, the HVTN seeks t o expedite and coordinate the trial process, advancing vaccine candidates and building a body of knowledge around HIV vaccine trials. The HVTN is funded and supported by the NIAID of the NIH, an agency of the U.S. Department of Health and Human Services (DHHS).
The HVTN comprises more than 25 research institutions worldwide, coordinated from its headquarters at the Fred Hutchinson Cancer Research Center in Seattle.
whsc.emory.edu/press_releases_print.c...

[verwijderd] 3 februari 2007 14:41

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Wash. men get hard-to-treat HIV strain
Fri Feb 2, 8:42 PM ET
SEATTLE - A hard-to-treat strain of the virus that causes

AIDS has been found in four gay men in King County, and authorities fear it could spread to more.
There is no evidence that the troublesome strain of HIV is spreading rapidly, but its appearance underscores the need for renewed emphasis on safe sex practices, officials in the Seattle-King County public health department said Thursday.
"There may be more cases we don't know about," said Dr. Bob Wood, the agency's HIV-AIDS program director.
"We are still working to learn more about these individuals and the virus they have contracted," said Dorothy F. Teeter, interim director of the department. "We are concerned for these individuals and their partners and are continuing our investigation."
The same genetic strain of HIV was found over a 15-month period in all four men, methamphetamine users who each had multiple partners, but none is known to have had sex with any of other three, officials said.
"That's highly unusual," said Dr. Peter Shalit, who treats HIV-AIDS patients and directs HIV-AIDS research at Swedish Medical Center.
One possibility is that there is a new strain of multi-drug-resistant HIV that is spread more easily than previous drug-resistant strains, "definitely a scary prospect," Shalit said.
"There's no evidence that this has spread outside of King County," said Dr. Patrick Sullivan, chief of the behavioral and clinical surveillance branch at the Atlanta-based Centers for Disease Control and Prevention.
But the center also hasn't compared this strain with ones outside of King County because the center studies disease from a population, not an individual, perspective, he said Friday in a telephone interview.
One man in New York, diagnosed with HIV in December 2004, was found to have a multi-drug-resistant type of HIV and he too had multiple, anonymous sexual partners, a history of methamphetamine use and had sex with men, according to the

CDC.
Nationally, 2 percent to 3 percent of the HIV strains that people are infected with may be resistant to two to three classes of drugs, Sullivan said.
While at least 100 King County residents die of AIDS annually, there is evidence of declining condom use and other safe-sex practices among gay drug users especially, said Wood, who is gay and has medically managed his own HIV infection for more than 20 years.
"There's a lot of complacency," he said. "People need to know that some of these new infections may be impossible to treat."
Seattle was among the first metropolitan areas in the country to begin a surveillance program for multi-drug-resistant HIV in 2003. Since then, doctors and other health care providers have been asked to test routinely for drug resistance in anyone who is HIV-positive and to report any indication of multi-drug-resistant strains.
Before Thursday, health officials had identified 12 cases of multi-drug-resistant HIV in the county, none as resistant to anti-viral drugs as the most recent four.
None of the four men has experienced any symptoms, Wood said, but experts fear that drug-resistant HIV could progress to AIDS much faster than typical HIV.
In addition, Dr. Robert D. Harrington, director of a Harborview Medical Center clinic for HIV patients, said treatment for those who are resistant to several types of drugs could cost more than twice as much as the $15,000 a year that is needed for typical HIV.
news.yahoo.com/s/ap/20070203/ap_on_he...
seattle_hiv;_ylt=Aps1IfRzphnT8UEWehFdlp_VJRIF;_ylu=X3oDMTA2Z2szazkxBHNlYwN0bQ--

[verwijderd] 5 februari 2007 12:11

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INTEGRASE INHIBITION — Newsletters

HIV News: Advances in HIV Treatment (file size: 138KB) This newsletter is based on promising preliminary data from our ogoing phase II trial program for the novel investigational HIV-1 integrase inhibitor MK-0518. It briefly discusses the prevalence of HIV/AIDS, the urgent need for new antiretroviral agents to address the growing problem of resistance, and the mechanisms of currently available therapies before focusing on the important role of integrase in viral replication, the novel mechanism of action of MK-0518, and the promising results seen with MK-0518 in protocols 004 and 005.

www.msd.com/pro/hiv/mk518/swf/HIV_New...

[verwijderd] 6 februari 2007 19:51

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Preclinical results of Geovax's AIDS vaccines demonstrate potential to protect against disease
Results complement encouraging human data

GeoVax Labs, Inc. (OTC BB: GOVX), an Atlanta-based biotechnology company, today reported successful results from a preclinical trial using GeoVax's vaccines for the therapeutic treatment and prevention of Acquired Immunodeficiency Disease Syndrome ("AIDS") in non-human primates. The data demonstrate the effectiveness of GeoVax's DNA/MVA vaccines in controlling the Simian ("SIV") AIDS virus through immune responses raised by the vaccines. These promising results have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's vaccines.
In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines.
The reduction of virus levels in the blood stream of these AIDS virus-infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.
"The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS," said Don Hildebrand, CEO of GeoVax Labs. "Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines."
The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.
The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.

www.geovax.com/public/GeoVax%20Press%...
www.geovax.com/public/GeoVax%20Press%...

[verwijderd] 7 februari 2007 00:02

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Statement of Anthony S. Fauci, M.D.
Director, National Institute of Allergy and Infectious Diseases
National Institutes of Health
on
National Black HIV/AIDS Awareness and Information Day
February 7, 2007

On February 7th, we commemorate the seventh annual National Black HIV/AIDS Awareness and Information Day. This day of recognition reminds us of the devastation that HIV/AIDS continues to inflict on African American communities. Although African Americans account for only 13 percent of the U.S. population, in 2005 they represented approximately 50 percent of new HIV/AIDS diagnoses. The Centers for Disease Control and Prevention (CDC) estimates that more than 211,000 African Americans with AIDS have died since the epidemic began. African Americans have long been disproportionately affected by HIV/AIDS, and that disparity has only deepened over time.
Scientists supported by the National Institutes of Health (NIH), in collaboration with colleagues around the world, continue to unlock the mysteries of HIV/AIDS and develop new strategies to prevent infection and to treat people living with HIV. Over the years research advances have positively affected lives of individuals and communities, here and abroad. Recent analyses suggest that at least three million years of life have been saved in the United States since the advent of combination antiretroviral therapy in the mid-1990s, highlighting the significant advances made in the treatment of HIV-infected individuals.
Scientists are now working to improve the treatment of HIV-infected people by developing new drugs and by defining the optimal use of current drugs. At the same time, NIH-supported researchers are making significant progress in developing new tools of HIV prevention, such as topical microbicides that individuals could use to protect themselves against acquisition of HIV infection. Promising research also has led to the development of multiple candidate HIV vaccines that are being testing in the United States and in countries around the world. A multifaceted and comprehensive approach to HIV/AIDS that includes diagnosis, prevention, treatment and care is the best strategy to fight this epidemic, and NIH-supported scientists will continue to lead the research endeavor with their dedicated partners worldwide.
Some of the biggest challenges we face today are the misperceptions of and lack of knowledge about HIV/AIDS, and fear related to clinical research, particularly among African Americans. I encourage African Americans to take part in the research effort in whatever way possible, as scientists, clinicians, community educators, advocates and study volunteers. To ensure that treatments and vaccines will work for everyone, volunteers in our clinical trials need to represent all racial and ethnic groups. As new vaccines, therapies, microbicides and other interventions enter the pipeline for clinical testing, tens of thousands of HIV-negative clinical trial volunteers will be needed. In this regard, NIAID recently initiated a new campaign to raise awareness of preventive HIV vaccine research, a campaign that includes a focus on African American communities with the hope of addressing some of these challenges (see www.bethegeneration.org).
National Black HIV/AIDS Awareness and Information Day is an opportunity to get involved and make a difference. Everyone should be encouraged to get tested for HIV, learn more about the disease and how it is transmitted, seek medical advice if infected, and become involved in local community efforts to educate people and fight this disease. I want to commend all the dedicated workers and the national, regional and local HIV/AIDS groups that have contributed to efforts to defeat HIV/AIDS since the disease was first identified. Now more than ever, we need to work together to end this epidemic.
Further information about National Black HIV/AIDS Awareness and Information Day is available at www.blackaidsday.org/. Information on prevention, treatment, and vaccine clinical trials is available at www.aidsinfo.nih.gov.
Dr. Fauci is director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health in Bethesda, Maryland.
www.nih.gov/news/pr/feb2007/niaid-05.htm

[verwijderd] 7 februari 2007 00:03

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IAVI at Ten
IAVI is now in its second decade of working to ensure the development of safe, effective preventive HIV vaccines for use throughout the world. As we commemorated IAVI's 10th anniversary in 2006, we took a retrospective look at how far the field has come since the mid-1990s — when the world was paying little attention to AIDS vaccines — to looking towards the future and finding an AIDS vaccine in the upcoming years.

Imagining A World without AIDS:

A History of the International AIDS Vaccine Initiative brochure

IAVI unveils its first Scientific Blueprint for
AIDS Vaccine Development as part of its strategic
plan to speed HIV vaccine development with
Vaccine Development Partnerships (VDPs)
comprised of scientists in industrialized and
developing countries.

The Dutch biotech firm Crucell N.V. grants IAVI
exclusive license to use its AdVac® adenovirus
vectors technology to develop an AIDS vaccine.

www.iavi.org/viewfile.cfm?fid=43574

[verwijderd] 8 februari 2007 22:06

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quote:
flosz schreef:
'Two of the most advanced trials underway in 2007 are from Sanofi-Pasteur and Merck & Co., Inc. Data from Merck’s ongoing Phase IIb test-of-concept trial with its adeno-5 vector vaccine candidate is expected in late 2007 or early 2008 and will provide preliminary information on the efficacy of this type of vaccine candidate. These results will have significant implications for the field's future research and development efforts. The company will also soon be starting an additional Phase IIb trial with the same candidate in South Africa.

Press Releases
February 8, 2007

First Large-Scale HIV Vaccine Trial in South Africa Opens
Four-year trial will enroll 3,000 participants throughout South Africa

A large-scale clinical trial of a candidate HIV vaccine—which previously showed promise in smaller studies in the United States and elsewhere—has now opened in South Africa. The study plans to enroll up to 3,000 HIV-negative men and women, making it the largest African HIV vaccine trial to date.

Conducted jointly by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN), the trial is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study vaccine, provided by Merck & Co. Inc. (Whitehouse Station, NJ), contains copies of only three HIV genes, not the entire virus, so it is impossible for a trial volunteer to become infected from the vaccine.

“Our best hope of ending the AIDS epidemic is a safe and effective vaccine,” says NIH Director Elias A. Zerhouni, M.D. “To achieve that goal requires the concerted effort of governments, scientists and private industry as well as participation by well-informed volunteers.”

“We applaud the South Africans for bringing this important trial to fruition. This international partnership exemplifies the model of collaboration needed to defeat HIV/AIDS,” says NIAID Director Anthony S. Fauci, M.D.

In South Africa the trial is called Phambili (“moving forward”). Also known as HVTN 503, it is a Phase IIb “test-of-concept” trial, the first such vaccine study in South Africa. This type of trial is designed to provide preliminary information on vaccine efficacy and thus enable researchers to decide whether or not to conduct a larger Phase III efficacy trial that could lead to licensure.

In smaller trials, the vaccine was found to be safe and to stimulate cellular immune responses against HIV in more than half of volunteers. To date, more than 1,800 people have received at least one injection. Two years ago, the first Phase IIb trial of the vaccine opened at sites in the United States, Canada, South America, Australia and the Caribbean (see www3.niaid.nih.gov/news/newsreleases/..., areas where a subtype of HIV called clade B predominates. That trial is ongoing.

As in that study, the main objectives of HVTN 503 are to determine whether the candidate vaccine can prevent HIV infection or, in those who do become infected, lower the level of HIV early on. Additionally, the new trial will determine if the vaccine, which is based on clade B HIV, has the potential to protect against the HIV clade C subtype prevalent in South Africa. Immune responses in the first several hundred volunteers will be assessed to ensure the vaccine induces promising immune responses in this population against the clade C virus before proceeding to full enrollment.

Study volunteers must be healthy, sexually active, HIV-negative men and women, ages 18 to 35 years old. Investigators will assign them at random to receive either the test vaccine or an inactive placebo injection. The trial is double-blind, meaning that neither the researchers nor the volunteers know which a participant has received. All volunteers will be regularly counseled about ways to reduce their risk of acquiring HIV, and they will be given condoms. Access to care and treatment for sexually transmitted infections will be provided, and because recent findings indicate that medical circumcision can reduce the risk of HIV transmission from women to men, access to medical circumcision will also be provided to male participants who desire it.

In South Africa, the trial is led by Glenda Gray, MBBCH, FCPaeds (SA), of the Perinatal HIV Research Unit, University of the Witwatersrand, based at the Chris Hani Baragwanath Hospital in Soweto. James Kublin, M.D., M.P.H., of Fred Hutchinson Cancer Research Center, Seattle, serves as study co-chair. The study is expected to recruit volunteers at five sites in South Africa, located in Soweto, Cape Town, Klerksdorp, Medunsa and Durban.

According to Dr. Gray, the study team has actively sought community endorsement of and support for this clinical trial, both of which are critical to its success. “Our communities here in South Africa are faced with the burden of HIV on a daily basis, and the trial investigators and study team have spent years developing a rapport with the community so that together we can move forward in our quest to identify improved approaches to prevent new HIV infections.”

The test vaccine contains a weakened adenovirus that serves as a carrier for three clade B HIV genes. Adenoviruses are among the main causes of upper respiratory tract ailments such as the common cold. Because the vaccine contains only three HIV genes housed in weakened adenoviruses, study participants cannot become infected with HIV or get a respiratory infection from the vaccine. The study aims to determine if the HIV genes will induce a cellular immune response, producing immune cells that recognize and kill cells infected with HIV.

The South African Medicines Control Council, the South African Department of Agriculture and the U.S. Food and Drug Administration have reviewed the trial and allowed the study to proceed. In order to conduct the trial, sites also are required to obtain institutional ethics and biosafety committee approvals.

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.
www.hvtn.org/media/pr/phamni.html
www.hvtn.org/media/pr/phamsa.html
www.hvtn.org/media/pr/phamfr.html
*******************************
HVTN 503
Q4 2006 (clade C sites)
Nonreplicating adenoviral vectors (clade B Gag-Pol-Nef)
Merck
MRKAd5 trivalent
chi.ucsf.edu/vaccine/vaccines?page=vc...
********************
Zie posting js238881
www.iex.nl/forum/topic.asp?forum=228&...

[verwijderd] 8 februari 2007 22:17

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Zie ook postings d.d. 21-12-2006, draadje Imagine, a vaccine
www.iex.nl/forum/topic.asp?forum=228&...

Safety and Efficacy of a Three-Dose Regimen of an Adenoviral HIV Vaccine (MRKAd5 HIV-1 Gag/Pol/Nef) in HIV Uninfected South African Adults
This study is currently recruiting patients.
Verified by National Institute of Allergy and Infectious Diseases (NIAID) December 2006

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
HIV Vaccine Trials Network
Merck Information provided by: National Institute of Allergy and Infectious Diseases (NIAID) ClinicalTrials.gov Identifier: NCT00413725

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter Double-Blind Randomized Placebo-Controlled Phase IIB Test-of-Concept Study to Evaluate the Safety and Efficacy of a Three-Dose Regimen of the Clade B-Based Merck Adenovirus Serotype 5 HIV-1 Gag/Pol/Nef Vaccine in HIV-1 Uninfected Adults in South Africa
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcomes: Acquisition of HIV-1 infection; viral load setpoint (HIV-1 RNA at approximately 3 months postdiagnosis) in study participants who become HIV infected
Secondary Outcomes: Acquisition of HIV-1 infection among participants with baseline Ad5 neutralizing antibody titers of 200 or less; viral load setpoint in such study participants; evaluation at 18 months after diagnosis of HIV infection of durability of effect of vaccine on suppression of HIV-1 viral RNA and preservation of CD4 counts
Expected Total Enrollment: 3000
The HIV epidemic is a major global health challenge. The Joint United Nations Program on HIV/AIDS (UNAIDS) reported that in 2004, 3 million people worldwide died of AIDS and an estimated 5 million people acquired HIV. Studies in animal models and observational data from humans suggest that cell-mediated immune responses may be key to controlling HIV infection. MRKAd5 HIV-1 gag/pol/nef, a clade B-based adenovirus serotype 5 HIV-1 vaccine, has been shown to elicit T-cell mediated immune responses. The vaccine appears to be safe and generally well tolerated in previous Phase 1 and 2 studies in HIV uninfected people. The purpose of this study is to evaluate the safety and efficacy of the MRKAd5 HIV-1 gag/pol/nef vaccine in HIV uninfected participants from South Africa, where clade C is predominant. The study will address whether a clade B-based vaccine designed to elicit T-cellular immunity will demonstrate efficacy in reducing acquisition of infection, or reducing HIV viral load in persons who become infected in a non-clade B region.
This study will last about 4.5 to 5.5 years. Participants will be randomly assigned to receive 3 doses of either vaccine or placebo. All participants will receive their injections at study entry and at Months 1 and 6. Participants will be asked to complete a post-vaccination symptom log for the 3 days following each vaccination to monitor body temperature and symptoms known to be associated with the vaccine. At all study visits, participants will be asked about any adverse events they may have experienced. There will be at least 14 study visits over the first 4 years of the study. A physical exam, medication history, risk reduction counseling, and blood collection will occur at every visit. Participants will be asked to complete a social impact questionnaire at Weeks 12, 78, and 208; an outside testing and belief questionnaire at Weeks 30, 78, 130, 182, and 208; and a circumcision status assessment at Week 208. Participants will undergo HIV testing to check their HIV status approximately every 6 months. Additional visits will be required for any participant who becomes infected with HIV during the study.

Study ID Numbers: HVTN 503
Last Updated: December 18, 2006
Record first received: December 18, 2006
ClinicalTrials.gov Identifier: NCT00413725
Health Authority: United States: Food and Drug Administration; South Africa: Medicines Control Council
ClinicalTrials.gov processed this record on 2006-12-20

clinicaltrials.gov/ct/show/NCT0041372...
*************************
This study will last about 4.5 to 5.5 years.

A companion study (known as the Step Study or HVTN 502/Merck 023) is
currently underway in the Americas and Australia
****************************
HVTN503FAQ_eng.doc Page 1 of 7
Questions and answers: HVTN 503 vaccine trial
Last updated November 8, 2006

1. What is the HVTN 503 trial?
HVTN 503, also known as Phambili, is a clinical trial to test the efficacy and safety of an
experimental HIV vaccine. The trial will be run by the HIV Vaccine Trials Network (HVTN) in
conjunction with the South African AIDS Vaccine Initiative (SAAVI) and the US National Institutes
of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS
(DAIDS), and with pharmaceutical support provided by Merck Research Laboratories (MRL). The
study will be conducted in the Republic of South Africa and is supported by the South African AIDS
Vaccine Initiative. A companion study (known as the Step Study or HVTN 502/Merck 023) is
currently underway in the Americas and Australia. The experimental vaccine, or “study vaccine,” is
described in Question 5 below.
The main purposes of this trial are to obtain more information about the safety of the experimental
vaccine (or “study vaccine”) in humans and to learn if the study vaccine has the potential to prevent
HIV infection or lower the level of HIV in the blood if someone becomes infected. Specifically, the
trial will investigate whether a vaccine designed to target Clade B HIV virus could potentially be
effective in regions where Clade C is predominant.
The product in this trial is not produced from live virus or from HIV-infected human cells. There is
no possibility that it contains live (or killed) HIV virus. There is no possible way that the product in
this trial can cause HIV infection.

5. What kind of vaccine is being tested?
The investigational vaccine is called MRKAd5 HIV-1 gag/pol/nef. It is composed of 3 adenovirus
vectors, each with an HIV gene insert.
A vector is a packaging system that can help deliver the vaccine more effectively into the part of the
body or cells to create an immune response. In this study vaccine, the vector is a weakened form of
adenovirus type 5 (Ad5), with key pieces removed so that the adenovirus cannot replicate in humans.
(If adenovirus replicates, it causes illnesses such as colds and respiratory infections.)
A synthetic insert consists of some extra genes added into the vector. In this case, the genes added are
HIV genes (gag, pol, and nef).

6. Why is this trial being done?
Based on the research that has been done so far, this study vaccine has shown promising
characteristics. After testing the study vaccine in the laboratory, in animals, and in some people (to
see if it is safe and if it provokes an immune response), researchers are interested in finding out more.
Specifically, they want to know if the vaccine has the potential to prevent HIV infection completely,
or if it can at least lower the level of HIV in the blood if a person becomes infected after getting the
vaccine.

gogogoo 8 februari 2007 22:20

Flosz,

Ik ben niet zo uptodate op het gebied van HIV.

Maar is "The study vaccine, provided by Merck & Co. Inc." (genoemd in het Artikel) met zekerheid het vaccin waar Crucell en Merck samen aan werken?

In het andere draadje zette jij eerder:
"Momenteel is Merck het verst (Phase II) met hun HIV vaccin waarbij momenteel 2500 mensen getest worden."

In het artikel van vandaag staat " Four-year trial will enroll 3,000 participants throughout South Africa" en Phase IIb.

"In South Africa the trial is called Phambili (“moving forward”). Also known as HVTN 503, it is a Phase IIb “test-of-concept” trial, the first such vaccine study in South Africa. This type of trial is designed to provide preliminary information on vaccine efficacy and thus enable researchers to decide whether or not to conduct a larger Phase III efficacy trial that could lead to licensure."

Is besloten om de trail uit te breiden of is dit een stap vooruit?

[verwijderd] 9 februari 2007 19:07

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Hoi gogogoo, een routebeschrijving...(neem een knapzak met lekkers mee...flesje water, flesje wijn, ik neem vaker de "verkeerde afslag", lol).
Bij het volgen van MRKAd5 HIV-1 Gag( Zie art. Ledwith BJ, Tumorigenicity assessments of Per.C6 cells and of an Ad5-vectored HIV-1 vaccine produced on this continuous cell line) kom ik bij << HVTN 050/Merck 018 (n=435)>> uit.
Bij het volgen van MRKAd5 HIV-1 gag/pol/nef (MRKAd5 trivalent) kom ik uit bij HVTN 502 en HVTN 503.
Nonreplicating Adenoviral Vector Vaccines, chi.ucsf.edu/vaccines/vaccines?page=v...

Lewis JA, Brown EL, Duncan PA.
Department of Live Virus Vectors, Merck Research Laboratories, Merck and Co., West Point, PA 19486, USA.
Approaches to the release of a master cell bank of PER.C6 cells; a novel cell substrate for the manufacture of human vaccines.
Dev Biol (Basel). 2006;123:165-76; discussion 183-97
At Merck and Co. we have developed a recombinant E1 deficient adenovirus type 5 vaccine vector for HIV-1 and have adopted the PER.C6 cell line as a cell substrate for the manufacture of this vector for Phase I and II clinical trials. The PER.C6 cell line was developed at Crucell by the transfection of human primary embryonic retinoblasts with a transgene of E1 constructed with a minimum of E1 coding sequences to preclude homologous recombination generating replication-competent adenovirus, between E1 sequences in PER.C6 and adenovirus vectors with E1 deletions of the same molecular coordinates. We have developed a Master Cell Bank (MCB) of PER.C6 cells under serum-free conditions of suspension culture from a vial of PER.C6 cells obtained from Crucell.
************
Dev Biol (Basel). 2006;123:251-63; discussion 265-6. Related Articles, Links
Tumorigenicity assessments of Per.C6 cells and of an Ad5-vectored HIV-1 vaccine produced on this continuous cell line.
Ledwith BJ, Lanning CL, Gumprecht LA, Anderson CA, Coleman JB, Gatto NT, Balasubramanian G, Farris GM, Kemp RK, Harper LB, Barnum AB, Pacchione SJ, Mauer KL, Troilo PF, Brown ER, Wolf JJ, Lebronl JA, Lewis JA, Nichols WW.
Department of Safety Assessment, Merck Research Laboratories, Merck & Co., Inc., West Point, Pennsylvania 19486-0004, USA. brian_ledwith@merck.com
PER.C6, a cell line derived from human embryonic retinal cells transformed with the Adenovirus Type 5 (Ad5) E1A and E1B genes, is used to produce E1-deleted Ad5 vectors such as the MRKAd5 HIV-1 gag vaccine. While whole, live PER.C6 cells are capable of growing as tumours when transplanted subcutaneously into immunodeficient nude mice at a high dosage, the process for vaccine production includes filtration steps and other methods which effectively preclude contamination by intact viable substrate cells. However, because of the neoplastic nature of this cell line, we carried out a series of investigations to assess the tumorigenic risk posed by residuals from the cell substrate in a vaccine. To address concerns about transmission of oncogenic DNA, we demonstrated that purified PER.C6 cellular DNA does not induce tumours in newborn hamsters or nude mice. To address concerns about other potential residuals, including hypothetical adventitious tumour viruses, we demonstrated that a PER.C6 cell lysate and a MRKAd5 HIV-1 gag vaccine produced on PER.C6 cells do not induce tumours in newborn hamsters or newborn rats. These results, in conjunction with the wide panel of viral safety tests performed on these cells, support the safety of the PER.C6 as a cell substrate for vaccine production.
*************************
The AdVac®-based IAVI program is at an advanced preclinical stage; the Merck program is currently in Phase II proof-of-concept studies in humans. It is based on Merck's in-house vector system and Crucell's PER.C6® production technology.
*********************************
HVTN 050
www.aegis.com/conferences/croi/2005/A...
**********************************
The Merck HIV vaccine is a replication-incompetent adenovirus type 5 construct that is E1 deficient and propagated in an E1-complemented PER.C6 cell line. It incorporates transgenes for gag, pol, and nef, which produce the corresponding proteins when taken up by host cells, inducing an immune response to the virus.

art. 2005.
Progress in Vaccine and Gene Therapy Strategies
www.genengnews.com/articles/chitem.as...
*****************************************************
Ook uit 2005.
Milestone Reached in Merck’s PER.C6 ®
-related investigational HIV Vaccine Program. On December
15, Crucell announced that Merck & Co., Inc. had met a clinical development milestone in connection
with the PER.C6 ®
technology licensed to Merck for its investigational HIV program. Merck has started
phase II clinical testing in the US, Caribbean and South America. (<<Ik mis hier vermelding van Australië?>>)

hugin.info/132631/R/983544/146425.pdf
Pagina 4.

En dan via
PB start HVTN 502
www.hvtn.org/media/press_releases.sht...

Naar "companion study " HVTN 503
www.hvtn.org/faq/503/HVTN503FAQ_eng.pdf
www.hvtn.org/science/trials.html

Data from Merck’s ongoing Phase IIb test-of-concept trial with its adeno-5 vector vaccine candidate is expected in late 2007 or early 2008 and will provide preliminary information on the efficacy of this type of vaccine candidate. These results will have significant implications for the field's future research and development efforts. The company will also soon be starting an additional Phase IIb trial with the same candidate in South Africa.

Via deze route kom ik weer uit bij PB van gisteren( ook onderdeel van Phase IIb):
Press Releases
February 8, 2007

First Large-Scale HIV Vaccine Trial in South Africa Opens
Four-year trial will enroll 3,000 participants throughout South Africa

A large-scale clinical trial of a candidate HIV vaccine—which previously showed promise in smaller studies in the United States and elsewhere—has now opened in South Africa. The study plans to enroll up to 3,000 HIV-negative men and women, making it the largest African HIV vaccine trial to date.

Conducted jointly by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN), the trial is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study vaccine, provided by Merck & Co. Inc. (Whitehouse Station, NJ), contains copies of only three HIV genes, not the entire virus, so it is impossible for a trial volunteer to become infected from the vaccine.

“Our best hope of ending the AIDS epidemic is a safe and effective vaccine,” says NIH Director Elias A. Zerhouni, M.D. “To achieve that goal requires the concerted effort of governments, scientists and private industry as well as participation by well-informed volunteers.”

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Vervolg...

“We applaud the South Africans for bringing this important trial to fruition. This international partnership exemplifies the model of collaboration needed to defeat HIV/AIDS,” says NIAID Director Anthony S. Fauci, M.D.

In South Africa the trial is called Phambili (“moving forward”). Also known as HVTN 503, it is a Phase IIb “test-of-concept” trial, the first such vaccine study in South Africa. This type of trial is designed to provide preliminary information on vaccine efficacy and thus enable researchers to decide whether or not to conduct a larger Phase III efficacy trial that could lead to licensure.
www.iex.nl/forum/topic.asp?forum=228&...
*************************
The Hope Clinic of the Emory Vaccine Center today announced that the Step Study, a multicenter international study of an HIV vaccine developed by Merck and Co., Inc., has successfully enrolled more than 2,800 people and expects to finalize enrollment within the next few months.
Cosponsored by the HIV Vaccine Trials Network (HVTN), the study plans to fill 200 slots at the participating sites in North and South America, the Caribbean and Australia.
*******************************
Er is nog vééééél meer, ook op het forum, maar .........
gr.

[verwijderd] 10 februari 2007 08:50

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IAVI Encourages Nations Worldwide To Support Advance Market Commitments To Combat Neglected Diseases

February 9, 2007 – The International AIDS Vaccine Initiative (IAVI) applauds the governments of Canada, Italy, Norway, Russia and the United Kingdom, as well as the Bill & Melinda Gates Foundation for their leadership and generosity in establishing a pilot Advance Market Commitment (AMC) program, an innovative financing mechanism aimed at accelerating the research, development and production of new vaccines. The AMC pilot plan for pneumococcal vaccines could help save the lives of millions of young children and infants and has the potential to be expanded to include vaccines to prevent other neglected diseases.

The lack of incentives available to encourage greater investment from the private sector, where most of the much-needed expertise in product development and manufacturing lies, is one of the biggest challenges facing the development of new drugs and vaccines to combat global infectious diseases. Uncertain market demand also raises a serious obstacle to industry involvement in research and development for global public goods. An AMC, which sets a guaranteed price for new drugs and vaccines in advance, is an important new initiative that could help to mitigate this risk and ultimately stimulate greater investment in urgently-needed health research.

"The AMC pilot could speed the development and delivery of new life-saving vaccines. It will complement and reinforce a number of ongoing efforts to promote these products," said Dr. Robert Hecht, Senior Vice President, Public Policy, IAVI. "We also need more direct financial support for research and development by the G8 and other governments, and we must explore the use of additional incentives," stated Dr. Hecht.

An AIDS vaccine offers the best hope for ending the AIDS pandemic and could play an important part in sustaining AIDS treatment and prevention programs. The exceptional scientific and financial challenges posed by the search for a safe, effective vaccine to prevent HIV infection must be matched by equal efforts to overcome them. Creative solutions, such as AMCs, could help to speed the development and widespread uptake of an AIDS vaccine.

"IAVI is pleased to have collaborated with the GAVI Alliance, the World Bank, the Center for Global Development and other vaccine public-private partnerships over the past two years to develop the AMC pilot program," said Dr. Hecht. "We will continue to support AMCs and other novel public policy initiatives that will help us to fulfill our mission of creating a vaccine that can help stem the spread of new HIV infections, now close to 12,000 per day."
www.iavi.org/

Zie o.a. ook
www.iex.nl/forum/topic.asp?forum=228&...

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Update on the STEP Study
Merck V520 Protocol 023/HVTN 502
October 2006.

MRKAd5 HIV-1 gag/pol/nef trivalent vaccine

Grown in PER.C6 cells (Crucell)

Pagina 5.

www.hvtn.org/ppt/oct06/RobertsonStep....,1,Update on the STEP Study Merck V520 Protocol 023/HVTN 502

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World focus on HIV vaccine trials

Published on: 2/12/07.
AS SOUTH AFRICA, a country with one of the highest rates of HIV/AIDS in the sub- Saharan region of Africa, prepares for a large-scale trial of an HIV vaccine, all the world will be watching for the results. The vaccine has been developed by Merck, a leading American drug company, and an international team of researchers, led by United States experts, will be overseeing the trials.
That South Africa will be the main focus of this study is a complete about-face for the country. For many years the authorities there had been reluctant to accept the efficacy of any pharmaceuticals in the treatment of the deadly disease, preferring to rely on home remedies. This early approach has been partly blamed for the rampant spread of the disease in South Africa where thousands were denied the benefits of early medicinal treatment because of this senseless policy.
The authorities have moved gradually away from this short-sighted approach towards dealing with the disease to the point where an estimated 3 000 HIV-negative men and women, who are sexually active, will be immunised in a four-year study.
The aim is to find how the vaccine will work on heterosexuals, especially women, who now have the highest numbers for HIV/AIDS in South Africa and other countries, in a world where it is estimated that 40 million people are living with the disease.
The vaccine has already had trials for safety and immunity response in North and South America, other African countries and Australia. Given this background, it is interesting why this emphasis has been placed on South Africa for the trials.
It is not as if South Africa has been driven to the point of desperation where it is now willing to try anything in its efforts to stem the spread of the deadly HIV virus. However, in almost one stroke the country now finds itself from being one where the treatment of HIV/AIDS patients was seen as being most backward, to a position where it could well be in the forefront of battling the disease. What is achieved in South Africa can help the whole world.
The world is waiting for an effective HIV vaccine as the level of HIV/AIDS continues to rise globally.
It is certain, however, that an effective vaccine will help remove the stigma and discrimination, since these attitudes are grounded in fear of a disease for which there is no cure, although it is now possible for HIV/AIDS patients to live productive lives when treated with antiretroviral medicines.
The experts have warned that producing a vaccine is no magic wand operation. The South Africa trials do not mean that a vaccine is just around the corner since there remains a complex process in getting there even if the South Africa trials prove successful.
For all that, what is about to take place in South Africa is being regarded as one of the most hopeful developments so far in fighting the spread of HIV/AIDS throughout the world.
www.nationnews.com/editorial/30284839...

gogogoo 12 februari 2007 21:46

Bedankt Flosz! Wat laat je antwoord gezien.

diederique 17 februari 2007 20:39

17.02.2007 07:21

Europäische Zulassung des HIV-Medikaments Darunavir bietet vorbehandelten Patienten eine wirksame neue Option mit FUZEON

Basel, Schweiz -

Die Kombination aus FUZEON und Darunavir erhöht die Wahrscheinlichkeit, eine nicht nachweisbare Viruslast zu erreichen

ein äusserst wichtiges Therapieziel

Die heutige bedingte Zulassung zur Vermarktung des neuen Proteaseinhibitors (PI) Darunavir (geboostert durch Ritonavir) in der Europäischen Union bietet Ärzten die Möglichkeit, eine wirksame neue Behandlungskombination mit dem Fusionsinhibitor FUZEON aufzubauen.

Die Kombination aus FUZEON und dem geboosterten Darunavir hat gezeigt, dass vorbehandelte Patienten eine bessere Chance haben, eine nicht nachweisbare Viruslast zu erreichen als mit geboostertem Darunavir ohne FUZEON.
Dieses äusserst wichtige Therapieziel ist mit besseren Perspektiven verbunden, wurde jedoch für lange Zeit als ein unrealistisches Ziel für Patienten mit einer Resistenz gegen zahlreiche medikamentöse HIV-Behandlungen gehalten.

"Es ist klar, dass wir im Jahr 2007 in eine völlig neue Ära eintreten, in der eine nicht nachweisbare Viruslust das primäre Ziel für alle vorbehandelten Patienten ist", sagte Dr. Anton Pozniak, Facharzt am Chelsea and Westminster Hospital, London. "Die Verfügbarkeit neuer wirksamer Therapien wie Darunavir/r in Verbindung mit FUZEON bietet den Patienten eine bessere Chance, dieses Ziel zu erreichen."

Die wachsende Zahl der Nachweise aus Studien wie TORO 1 und 2, RESIST 1 und 2, POWER 1 und 2(2) hat dazu geführt, dass in einflussreichen internationalen Richtlinien die Kombination von Arzneimitteln mit einem neuen Wirkungsmechanismus, wie FUZEON, mit einem wirksam geboosterten PI, wie z.B. Darunavir/r, als einer der besten Ansätze für das Erreichen einer nicht nachweisbaren Viruslast bei vorbehandelten Patienten empfohlen wird.(3,4,5,6) Zu den Folgen der Aufrechterhaltung einer zunehmend versagenden Therapie bei einem Patienten, gehört das Auftreten einer Medikamentenresistenz und der rasche Verlust dringend benötigter wirksamer Behandlungen.

Dr. Malte Schutz, International Medical Leader bei Roche, erklärte weiter: "Wir begrüssen die europäische Zulassung des Arzneimittels Darunavir/r von Tibotec und wir wissen, dass dies eine wichtige Entwicklung für Patienten ist, die unter einer mehrfachen Arzneimittelresistenz leiden und die am dringendsten neue Behandlungsmöglichkeiten brauchen."

Literaturhinweise:

1. Lohse N, Kronborg G, Gerstoft J, et al. Virological control during the first 6-18 months after initiating highly active antiretroviral therapy as a predictor for outcome in HIV-infected patients: a Danish, population-based, 6-year follow-up study. CID 2006; 42:136-144.

2. Youle M, Staszewski S, Clotet B et al. Concomitant use of an active boosted protease inhibitor with enfuvirtide in treatment-experienced, HIV-infected individuals: recent data and consensus recommendations. HIV Clinical Trials 2006: 7: 86-96.

3. The Panel on Clinical Practices for Treatment of HIV Infection convened by the Department of Health and Human Services (DHHS).

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. May 4, 2006 AIDSinfo.nih.gov (accessed August 10 2006).

4. Recommandations du groupe d'experts sous la direction du Professeur Patrick Yeni réalisé avec le soutien du Ministère de la Santé et des Solidarités. Prise en charge médicale des personnes infectées par le VIH. 2006: 46.

5. Hammer SM, Saag MS, Schechter M et al. Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society -USA panel. JAMA, 2006;296:827-843.

6. British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy. British HIV
Association HIV Medicine (2006) 7, 494.

Hinweise für Redakteure:

Für weitere Informationen zu FUZEON und Roche bei HIV besuchen Sie bitte folgende Internet-Seite:

www.roche-hiv.com/Newsandfeatures/fuz...

FUZEON wurde im März 2003 von der FDA zugelassen und ist der erste und einzige Fusionsinhibitor für die Behandlung von HIV; FUZEON wirkt auf eine Weise, die sich von anderen Arten der Anti-HIV-Medikamente
unterscheidet. Darunavir, auch als TMC 114 und unter dem Handelsnamen Prezista(TM) bekannt, ist ein Produkt von Tibotec Pharmaceuticals Ltd., einem Unternehmensbereich von Janssen-Cilag. Darunavir gehört zur Klasse der PI und ist bekanntermassen wirksam gegen ein Virus, das eine Resistenz gegen andere PIs entwickelt hat.

Die Boosterung von PIs ist eine therapeutische Strategie, wobei eine geringe Dosis Ritonavir gleichzeitig mit einem anderen PI verabreicht wird, um die Wirkung des letzteren PI durch die Hemmung
des Enzymzytochroms P450 pharmakologisch zu verbessern. Die Boosterung durch Ritonavir führt zu erhöhten Medikamentspiegeln, welche die Wirksamkeit steigern, die Tablettenbelastung senken, den
Dosierungsplan flexibler gestalten lassen und Diätbeschränkungen aufheben können. Um anzuzeigen, dass ein PI durch Ritonavir geboostert wurde, wird das Zeichen "/r" dem Namen des PIs nachgestellt.

Alle in dieser Pressemitteilung verwendeten oder erwähnten Marken sind gesetzlich geschützt.

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: www.presseportal.ch

Pressekontakt: Für weitere Informationen wenden Sie sich bitte an: Peter Impey oder
Janet Kettels, Ketchum Hoffmann-La Roche Inc, Büro:
+44(0)20-7611-3589, Mobiltelefon: +44(0)7976-734493, E-Mail: peter.impey@ketchum.com; Büro: +1-973-235-4093, Mobiltelefon:
+1-862-596-9084, E-Mail: janet.kettels@roche.com

diederique 18 februari 2007 23:11

Are We Spending Too Much On HIV?

Billions of pounds are being spent on the fight against AIDS in developing countries. In this week's BMJ, two experts go head to head over whether we are spending too much.

HIV is receiving relatively too much money, with much of it used inefficiently and sometimes counterproductively, argues Roger England, Chairman of Health Systems Workshop.

Data show that 21% of health aid was allocated to HIV in 2004, up from 8% in 2000. It could now exceed a quarter. Yet HIV constitutes only 5% of the burden of disease in low and middle income countries as measured by disability adjusted life years lost (DALYs). It causes 2.8 million deaths a year worldwide - fewer than the number of stillbirths, and much less than half the number of infant deaths. More deaths are attributable to diabetes than to HIV.

Furthermore, HIV interventions are not cost effective enough to justify this disproportionate spending, he writes. Much HIV money could be spent with more certain benefits on, for example, bed nets, immunisation, or family planning. Money is also wasted in areas that reflect the interests of those on the AIDS industry payroll more than evidence.

He believes that the money could be more effective if used to strengthen public health systems rather than focusing on disease-specific programmes.

AIDS is widely acknowledged as a public health crisis and current spending is woefully inadequate, argue Paul de Lay and colleagues at the Joint United Nations Programme on HIV and AIDS (UNAIDS).

Resources currently pledged are only half of what is needed for a comprehensive response. For instance, in 2006, $9bn was available for the AIDS response but the real need was estimated at $15bn. Poor coordination between different stakeholders in affected countries also impedes effective spending. This is compounded by weak institutions and regulatory policies, poor governance, and in some cases corruption.

They argue that the response to AIDS needs to be seen in the context of international commitments to the millennium development goals, which also call for progress across many other developmental priorities. HIV threatens many of these goals, especially those related to poverty and health.

The cost of inaction against AIDS is huge, far greater than for any other public health crisis, they say. Current costs are so high because of the inadequacy of previous investments, but they will be higher tomorrow if we continue to underinvest.

###

Contact: Emma Dickinson
BMJ-British Medical Journal

www.medicalnewstoday.com/medicalnews....

aossa 24 februari 2007 17:50

February 23, 2007

New AIDS drugs aim to combat resistant HIV strains

By Deena Beasley and Ransdell Pierson

LOS ANGELES/NEW YORK (Reuters) - More than 25 years into the AIDS epidemic, many drugs are used to treat HIV, but an alarming number of patients are becoming resistant to therapy, driving research into new ways to combat the virus.

Data from clinical trials of several promising new products will be unveiled at a conference of leading HIV researchers in Los Angeles next week.

"There is a confluence of new drugs in the pipeline that people are pretty excited about," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

These include next-generation versions of longstanding HIV fighters as well as drugs that combat the virus through innovative mechanisms, including blocking it from entering immune system cells.

The human immunodeficiency virus that causes AIDS infects more than 1 million people in the United States and nearly 40 million worldwide. An estimated 40,000 Americans become infected each year.

About half of U.S. patients treated for infections with HIV have stopped responding to at least one drug, said Dr. John Mellors, chief of infectious diseases at the University of Pittsburgh.

Resistance is becoming a problem because the virus can mutate, particularly if patients fail to rigorously follow complicated drug regimens.

On Tuesday, Merck & Co. will release results of a trial of MK-0518, which is likely to be the first in a new class of drugs, known as integrase inhibitors, designed to block genetic information needed for HIV to reproduce. Merck plans to seek U.S. approval for the drug in the second quarter.

"It looks like a very exciting result," said Mellors. He said clinicians are starting to see response rates in patients previously heavily treated for HIV that are similar to effectiveness seen among first-time patients.

On Wednesday, Gilead Sciences Inc., maker of top-selling HIV pill Truvada, will present data from a mid-stage trial of its experimental integrase inhibitor,

GS-9137.

Norbert Bischofberger, head of research for Gilead, said comparisons with Merck's data would be problematic because patients in the Gilead study were not allowed to use other therapies until the company obtained information on potential drug interactions.

About four months into the six-month Gilead study, patients were allowed to use protease inhibitors, a commonly used family of HIV drugs, he said.

Another promising new class of medicines works by blocking HIV from entering and taking up residence in T cells, a type of white blood cell vital to the immune system.

The drugs work by jamming receptors -- or docking stations -- that dot the surface of the T cells and act as doorways into the cells. If HIV is barred entry, the virus cannot replicate.

Because the receptors are made of a protein called CCR5, the crop of drugs are called CCR5 inhibitors.

On Tuesday, Pfizer Inc. will present data from a late-stage trial of its CCR5 inhibitor, maraviroc, now awaiting U.S. and European approval. Patients in the trial had fared poorly on previous HIV treatments.

"If maraviroc is approved, it would change the landscape of treatment and be the first new oral class of HIV treatments in a decade, since the approval of protease inhibitors," said Howard Mayer, a Pfizer executive in charge of maraviroc's development.

Because CCR5 inhibitors do not attack the virus itself, as all four existing classes of HIV treatments do, Mayer said HIV might be less able to come up with ways of resisting their effects.

On Wednesday, Johnson & Johnson, which last year launched its first AIDS drug, Prezista, will announce results from a mid-stage trial of its next-generation non-nucleoside reverse transcriptase inhibitor, known as TMC278, which works by blocking an enzyme the HIV virus needs to replicate.

The 14th Conference on Retroviruses and Opportunistic Infections will be held at the Los Angeles Convention Center.

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