Published on Tuesday, February 6, 2007 by OneWorld US
AIDS Activists Optimistic Despite Clinical Setback
by Haider Rizvi
NEW YORK - Despite a setback in clinical trials, health advocacy groups remain supportive of the need to develop a biomedical product that women can use to protect themselves against HIV infection.
Last week, researchers announced they had stopped testing the effectiveness of Cellulose Sulfate after experts on safety-related issues suggested it might be contributing to an increased risk of HIV infection among trial participants.
Sponsored by CONRAD, an international reproductive health research organization, the tests were carried out in Benin, India, South Africa, and Uganda--countries with high rates of HIV infection.
Family Health International (FHI), a non-profit group, said it conducted similar experiments in Nigeria, but did not find any evidence of increased risk of HIV infection. The group, however, decided to discontinue its study as a precautionary measure.
Cellulose Sulfate was one of four microbicides undergoing trials for prevention of HIV and other sexually transmitted diseases. Microbicides are products that, though still under development, would help reduce the transmission of HIV during sexual intercourse. They could take the form of a gel, cream, tablet, or sponge, or be contained in a vaginal ring.
At this point, it is not clear why use of Cellulose Sulfate was associated with an increased risk of HIV infection. But the Independent Data Monitoring Committee, which examined the trial, has said it will conduct a detailed review of the data.
"It was our hope that this product would have helped women in protecting themselves," said Dr. Lut Van Damme, who led the investigations. "While the findings are unexpected and disappointing, we will learn scientifically important information from the trial that will inform future research."
Health activists say they fully back research efforts on HIV prevention options such as microbicides because in many societies women don't always have the right or opportunity to refuse sex or demand a condom.
"Of course, we wish the results had been different," said Lori Heise, director of the Global Campaign for Microbicides, "but learning what doesn't work can be just as important to progress as learning what does work."
Though disappointed with the trial results, Heise and other activists seemed pleased with the fact that independent monitoring bodies were in place to identify problems at the early phase of the trial.
Scientists scrutinized the data available on Cellulose Sulfate before the Phase III trials started, including safety results from 11 clinical trials involving 500 participants in Africa, India, and the United States. Health activists said all the data suggested that the product was safe.
"This is a setback but does not distract from the issue that women still don't have the tools they need to protect themselves from HIV," said Manju Chatani, coordinator of the African Microbicide Advocacy Group.
"African women urgently need more prevention options," she added, "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."
Mitchell Warren, director of the AIDS Vaccine Advocacy Coalition, agreed with Chatani.
"Getting a negative result for one product certainly doesn't signal failure for the microbicide field or biomedical HIV prevention research effort as a whole," he said, adding that each trial result "is a puzzle piece. Together, they make up the complex picture that will show us how to develop successful tools."
Currently, an estimated 39.5 million people in the world are living with HIV. More than half of all new infections last year--2.8 million--occurred in sub-Saharan Africa, while significant increases were also reported in Eastern Europe and East and Central Asia.
Last year, a UN report suggested that married women in their 20s and 30s were the most vulnerable to HIV infection, because they often did not have the power to ensure their husband's fidelity or demand he use a condom.
Researchers say the epidemic has multiple effects on women, such as the added responsibility of caring for sick family members, loss of income and property, and even suffering violence when their HIV status is discovered.
Stressing the need for further research on microbicides, activists noted that many women in Africa volunteered for Cellulose Sulfate trials because they knew how urgent it was for them to have new tools for prevention.
"It is essential to build on what has been learned here and proceed with research as rapidly as possible," said Heise about the failed trial. "Millions of women's lives are at stake."
Copyright © 2007 OneWorld US