Press Release

Leading advocates express support for microbicide research, despite disappointing clinical trial results

HIV prevention advocates from three major civil society organizations today emphasized the importance of continued research into new HIV prevention options, despite the recent discontinuation of the Phase III effectiveness trials of the microbicide candidate, cellulose sulfate (CS).

CS was one of the four microbicide candidates in Phase III effectiveness trials for prevention of HIV and other sexually transmitted infections. CONRAD, a reproductive health research organization, was conducting Phase III trials to assess its effectiveness in Benin, India, South Africa, and Uganda. Another Phase III trial of CS sponsored by Family Health International was underway in Nigeria. Both sponsors are not-for profit research groups dedicated to advancing health in developing countries.

At the recommendation of their respective Data Safety Monitoring Boards both sponsors chose to discontinue their CS trials after findings from the CONRAD trial suggested that CS might be contributing to an increased risk of HIV infection. Although review of the data from the Nigerian trial found no evidence of increased risk, FHI felt that the only responsible course of action was to halt its study also.

“Of course we wish the results had been different, but learning what doesn’t work can be just as important to progress as learning what does work,” observed Lori Heise, Director of the Global Campaign for Microbicides (GCM). “It’s also reassuring that the independent Data Safety and Monitoring Committees, put in place to identify problems early on in a trial, appear to have worked well. Advocates have been instrumental in pushing for extra mechanisms to help protect participant safety.”

African advocates are following the trials conducted in their countries particularly closely, reported Manju Chatani, Coordinator of the African Microbicide Advocacy Group (AMAG).  “Scientists scrutinized the data available on cellulose sulfate before the Phase III trials started, including safety results from 11 clinical trials done in Africa, India and the US. All the data suggested that the product was safe and should proceed into Phase III trials,” she said.

“This is a setback but it does not detract from the issue that women still don’t have the tools they need to protect themselves from HIV”, Chatani added. “And African women, especially, urgently need more prevention options. So while we need concrete answers to why this happened as soon as possible, we must continue to research new options so women don’t have to ask for permission to protect themselves”

Dr. Kim Dickson, an African physician who serves on the boards of both GCM and AMAG, noted that care and treatment of trial participants are among the top concerns of both groups, along with clinical trial ethics. “At civil society’s insistence, the trial investigators forged written agreements in advance to assure that any women who sero-converted while enrolled in the trial would get ongoing care and treatment, including anti-retroviral drugs as needed”, she said. “Our priority now is to make sure that advocates’ and community questions about this trial and future research are heard and addressed as soon as possible.”

Adding his perspective, Director of the AIDS Vaccine Advocacy Coalition (AVAC) Mitchell Warren observed that “Getting a negative result for one product certainly doesn’t signal failure for the microbicide field or broader biomedical HIV prevention research effort as a whole. The nature of research is that the information gathered is cumulative”, he continued. “Each trial result is a puzzle piece and, together, they make up the complex picture that will show us how to develop successful new HIV prevention tools.”

Heise concluded by noting that “The real heroines and heroes in this are the people who enroll in clinical trials because they know how urgently new prevention tools are needed. In Benin, South Africa, and Uganda, the African countries in which the CS trials were being done, between one third and one half of all women of reproductive age are already HIV positive”, she added. “It is essential to build on what has been learned here and proceed with the research as rapidly as possible. Millions of women’s lives are at stake.”

# # #

The Global Campaign for Microbicides is an international movement of activists, citizens and not for profit organizations dedicated to accelerating access to new HIV prevention tools, especially for women. www.global-campaign.org. Dr. Kim Dickson. +41 (22) 791 4548; cell: + 41 79 368 6259.

The African Microbicides Advocacy Group (AMAG) is a coalition of microbicide advocates from organisations and institutions based and/or working in various African countries. www.globalcampaign.org/amag.htm. Contact: [email protected]; + 233 21 225 180; cell: +233-244-503026

The AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other HIV prevention options.
www.avac.org.
Contact: [email protected], +1 212 367 1084.

Contact for Family Health International: Beth Robinson, + 1 919 405 1461, [email protected],
http://www.fhi.org/en/AboutFHI/Media/index.htm

Contact for CONRAD: Annette Larkin, +1 202 429 4929, cell: +1 703 772 6427,
[email protected]

Press Release

HIV Vaccines and Microbicides Resource Tracking Working Group Releases Preliminary Data and Launches New Website

The HIV Vaccines and Microbicides Resource Tracking Working Group was established in 2004 to generate and disseminate high-quality, detailed and comparable data on annual investments in preventive HIV vaccine and microbicide research and development (R&D), and policy and advocacy activities. These data can be used to monitor current levels of effort; identify trends in investment, spending, and research focus; identify areas needing more resources and effort; assess the impact of public policies aimed at increasing investment in new prevention technologies (NPTs); and provide a fact base for policy advocacy on R&D investments and allocations.

The Working Group is comprised of the AIDS Vaccine Advocacy Coalition (AVAC), the Alliance for Microbicide Development (AMD), the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS).

To coincide with the current UNGASS review taking place this month, the Working Group has generated new estimates of public sector investment in HIV vaccine and microbicide research, development, and advocacy in 2005.

According to a preliminary report, the public sector invested an estimated US $654 million in preventive HIV vaccines and about US$ 139 million in microbicides in 2005. A full report on global investment in these technologies – including funding from philanthropic institutions and private industry – will be available in August 2006.

We have launched a new website at http://www.hivresourcetracking.org/ has this latest report as well as the reports published on each technology in 2005 along with PowerPoint slide presentations with the report results.

For more information on HIV vaccines, please contact the AIDS Vaccine Advocacy Coalition ([email protected]) or the International AIDS Vaccine Initiative([email protected]).

For more information on microbicides, please contact the Alliance for Microbicide Development ([email protected]).

For more information on UNAIDS resource tracking activities, please contact the UNAIDS Resource Tracking Unit ([email protected]).

2003 AVAC Report: 4 Years and Counting: How do you Fight a Disease of Mass Destruction?

When America became frightened by the bio-terror threat, Congress and the Administration moved swiftly to put funding and incentives in place. That same kind of decisive action is needed to accelerate research and ensure an AIDS vaccine is available to all who need it. This Report looks at the bioterror model, and provides the results of our new industry survey.

2002 AVAC Report: 5 Years and Counting: Science, Urgency and Courage

Five years away from the date former President Bill Clinton set as a goal for finding an AIDS vaccine, there are more candidate vaccine products in development than ever before. No one knows if any of the current experimental vaccines will work. No one even knows what immune response a vaccine needs to elicit to prevent HIV disease. The only way to obtain answers is to ask tens of thousands of altruistic and courageous participants to participate in dozens of trials. The only way to obtain answers is to invest hundreds of millions of dollars to fund these trials.

2001 AVAC Report: 6 Years and Counting: Can a Shifting Landscape Accelerate an AIDS Vaccine?

In 1996, AVAC was the first organization to demand that development of an AIDS vaccine become a national goal. President Clinton set that goal in May 1997, calling for a successful vaccine by 2007. We are now six years away from the goal and counting. None of the challenges are insurmountable. The optimism that characterizes HIV vaccine research today should drive policy makers and researchers to grapple effectively with the issues that remain. An HIV vaccine is possible. The question is how soon we find it, and who gets it when we do.

2000 AVAC Report: 7 Years and Counting: How Can We Overcome Obstacles to an AIDS Vaccine?

The last year was one of great activity across US agencies and throughout the world. This Report documents the steadily increasing activity in the quest for a vaccine against HIV. We have also identified several actions necessary to accelerate development of HIV vaccines, and we outline all of this in the AVAC Report for 2000.

1999 AVAC Report: 8 Years and Counting: What Will Speed the Development of an AIDS Vaccine?

This Report urges government, industry, and community to dedicate themselves to the development of a safe and effective HIV vaccine. If the goal for 2007 cannot be achieved, then we need to know what will be accomplished over the next eight years toward a vaccine that could bring the HIV pandemic under control. With 16,000 new HIV infections each day, the world can afford no delay. This Report describes what each of these sectors has accomplished during the past year and outlines what each can do to speed the search for a preventive vaccine.

1998 AVAC Report: 9 Years and Counting: Will We Have an HIV Vaccine by 2007?

This report surveys the public- and private-sector efforts on HIV vaccine research and development in the past year, with a focus on the US government agencies and pharmaceutical companies that are most likely to make a difference. It finds that, despite an impressive array of dedicated researchers and increasing funding for HIV vaccines, the world will fall short of President Clinton’s deadline. US government research efforts are not focused on results, leaders err on the side of caution rather than on moving forward, responsibility is diffuse, and the nation has stood silent as pharmaceutical companies, including the world’s largest vaccine producer, make little or no investment in one of the greatest public health challenges of our century. AVAC addresses these obstacles and recommends an agenda for action in this report.