[Press Kit, International Conference on AIDS (13th : 2000 : Durban, South Africa)]

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WHAT DO RESULTS OF THE UNAIDS TRIAL ON COL-1492 (ADVANTAG -S)
SAY ABOUT THE FEASIBILITY OF MICROBICIDES?
Background:
Preliminary results to be released at the XIII World Conference on HIV/AIDS in Durban
indicate that Advantage-S, an existing over-the counter spermicide containing 52 mg. of
Nonoxynol-9, does not offer women protection against HIV transmission. Indeed, the data
suggest that when used many times a day, as was the case among the sex workers enrolled
in this trial, Advantage S may increase the risk of transmission slightly compared to
placebo, possibly through creating small disruptions in the vaginal cell wall (epithelium).
The current trial enrolled sex workers in Cote d'Ivoire, Thailand and South Africa. Women
were offered free condoms and counseling as well as STD testing and treatment throughout
the trial. Women were randomized into one of two arms, one of which received the test
product and the other a placebo. Both groups were encouraged to use the product AND a
condom at each act of intercourse.
Prior to advancing to large-scale effectiveness trials (Phase III) the Advantage-S product
underwent extensive safety trials in humans. These trials indicated that the product was
safe to use and did not cause genital sores or lesions.
The Global Campaign Response:
The Advantage-S trial results do not suggest that effective vaginal and rectal
microbicides cannot be found - only that Advantage-S probably isn't one of them.
* Advantage-S was developed and marketed as a contraceptive, not as a method to
prevent HIV or other infections. UNAIDS decided to evaluate its effectiveness for
disease prevention in the hope that something that killed sperm would also prove
effective against HIV. The fact that it did not prove effective against HIV is
disappointing, but not surprising.
* Other products in the microbicide pipeline contain varying amounts of Nonoxynol-9,
the active ingredient in Advantage-S, making it impossible to generalize the findings
regarding one product to other N-9 containing products.
* The most promising product leads are furthest back in the product pipeline.
* The decision as to whether to proceed with trials of other N-9 products should be
made only after careful review of the full data from the UNAIDS trial. Trial sponsors
should convene a consultative group-including women's health advocates-to make
this decision.
The failure of Advantage-S to show protection in the UNAIDS trial underscores the
urgent need to accelerate research into topical microbicides. Presently, the US
National Institutes of Health spends only 1% of its AIDS budget on microbiciderelated research. With infection rates climbing dramatically among women, the
global community must intensify its efforts to advance other promising leads into
human testing.
Global Campaign for HIV/STI Prevention Alternatives for Women, Takoma Park, MD. July, 2000. For info. contact:
[email protected].