HIV Prevention Advocates Welcome Promising News on Microbicides

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HIV Prevention Advocates Welcome Promising News on Microbicides

Today, the US National Institutes of Health announced promising results of a

multi-site clinical trial of two candidate microbicides, topical products

designed to reduce the risk of HIV when applied vaginally before sex. Known as

HPTN 035, the trial was conducted by the NIH-funded Microbicide Trials Network

and led by Salim S. Abdool Karim, Ph.D. from the University of KwaZulu-Natal in

Durban , South Africa . Dr. Karim headed a team of leading African and U.S.

researchers working at trial sites in South Africa , Malawi , Zambia , Zimbabwe

and the United States .

The trial found that women who were offered PRO2000 gel plus condoms had 30

percent fewer HIV infections than those offered only condoms or condoms plus a

placebo gel. Reported adherence to the gel was high at 81 percent. In another

analysis that accounted for the time that women did not use product because they

were pregnant, the study found PRO2000 to be 36% protective against HIV compared

to the control arms. The other candidate microbicide tested, BufferGel, did not

reduce HIV risk among women.

The results on PRO2000 are a ray of hope for women,†observed Lori Heise,

Director of the Global Campaign for Microbicides (GCM), an advocacy organization

that has been campaigning to expand women’s HIV prevention options for over a

decade. “This is the first time that we have had human data actually showing

that a vaginal gel can work to reduce infection. It’s not a home run, but

this “proof of concept†should invigorate the field.â€

Another effectiveness trial of PRO2000, conducted by the UK-funded Microbicide

Development Programme (MDP), is currently in its final stages in South Africa,

Tanzania , Uganda and Zambia . This trial—known as MDP 301--has enrolled

over 9,000 women, three times the number enrolled in HPTN 035.

This second trial should help us refine our estimate of how effective PRO2000

actually is,†noted Dr. Samu Dube, GCM’s Africa Program Leader. “With

three times the number of women, the MDP trial will yield an even more precise

estimate of effectiveness. We will need such data before deciding whether it

makes sense to move this product forward toward licensing and distribution.â€

On Wednesday, GCM will host a global conference call for prevention advocates to

discuss the new microbicide findings as well as promising data simultaneously

released by the CDC on the ability of both oral pills and vaginal gels

containing the anti-retroviral drug tenofovir to fully protect monkeys from HIV

infection. Â Significantly, the next generation of microbicide trials will focus

on candidates that incorporate the same highly potent anti-retroviral drugs that

have been successfully used for AIDS treatment. Already a trial evaluating a

tenofovir-based microbicide is underway in South Africa .

Much remains to be done before we will have a viable product to distribute,â€

notes Dube, “But as an African woman, a physician, and a mother, my message is

that this is a great day for women and for prevention research.

Paramita Kundu

Programme Associate , India

Global Campaign for Microbicides

PATH

A-9 Qutab Institutional Area

New Delhi 110067

Telephone: 91-11-26530080

Fax:91-11-26530089

Email: pkundu@...