Microbicides News Archives

Spring - Summer News

Long-awaited microbicides branch at U.S. National Institutes of Health North America
Global Campaign News #84

On 23 July, the U.S. National Institutes of Health (NIH) formally approved plans to establish a microbicide branch. The branch, would be dedicated to microbicide research and development within the NIH's National Institute of Allergy and Infectious Diseases, thereby creating a single line of administrative accountability and providing direction to ensure microbicide research and development is prioritized.

This announcement signals a long awaited victory for microbicide advocates. Microbicide research at NIH has long been conducted under several institutes with no single line of administrative accountability and highly variable levels of interest and commitment across institute leadership. Now, the question looms: What does this mean for the future of the Microbicide Development Act?

The NIH decision is a welcome development, but it does not diminish the need for Congress to pass the MDA. It is, instead, the first step on the road toward strengthening and coordinating the federal government's microbicide research and development efforts.

The MDA will ensure the coordination within and among all of the relevant federal agencies - the National Institutes of Health, the U.S. Agency for International Development, and the Centers for Disease Control and Prevention. The MDA will also help establish and sustain the allocation of a reasonable and reliable level of resources. Finally, enactment of the MDA will provide clear and lasting evidence that funding research on microbicides is a priority, and that Congress is interested and will engage in continued oversight of microbicide programs.

 

AUSTRALIA:
"Still No Verdict on Anti-HIV Gel" back to top
Business Day (Johannesburg), (07.26.2007) Tamar Kahn
Results from a study of the vaginal microbicide candidate Ushercell suggest it was not effective in preventing HIV infection, researchers told this week's 4th International AIDS Society Conference in Sydney. The gel contains cellulose sulphate, a cotton-based compound.

"We don't think it's effective, and there may be an indication of increased risk [of contracting HIV]," said Lut van Damme, international clinical research manager at Conrad, a US-based research group. Interim analysis of data from the trial, which enrolled about 1,400 women, showed 25 who used Ushercell contracted HIV, compared to 16 women using a placebo. Based on that data, Conrad shut down the trial in January.

Ten previous studies and two contraceptive trials had shown the gel was safe.

Van Damme said the surprising interim data might have several explanations. She said Ushercell might have caused irritation or disturbed the natural vaginal flora. A new US safety study of Ushercell is planned involving 60 women, said van Damme. "It would be unethical not to try and understand what's going on," she said.

An Ushercell trial in Nigeria was stopped when Conrad's trial was suspended, even though its data showed no apparent increased risk of HIV among those using the gel, Willard Cates of Family Health International told the conference.
 

UNITED STATES:
"Trials Begin on HIV Gel for Women"
Australian Associated Press, (07.10.2007)
Forty US women are taking part in a two-week trial of a vaginal microbicide designed to block HIV and other STDs, Australia-based Starpharma Holdings Ltd., the drug's maker, said today. VivaGel is currently being tested at the University of South Florida and the University of Puerto Rico in sexually active, HIV-negative women ages 18-24.

The goal of the US National Institutes of Health-funded trial is to determine the safety and ease of use of VivaGel, said Dr. Jackie Fairley, StarPharma's chief. "We have already conducted clinical trials on the safety of VivaGel in sexually inactive women and men, but this is the first time the product will be used in sexually active young women, one of our target populations," said Fairley.

The drug maker cited statistics that show 60 percent of US women with HIV are in the 15-24 age group, highlighting how critical such a product could become to young women.

"This study, in addition to the usual safety data, will collect valuable information regarding the product's use and acceptability in the consumer setting," said Fairley. "The data from this trial will provide information of value to the development of VivaGel for all indications, including preventing the spread of genital herpes."

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