Re: NARI microbicides research in India

[Guest guest]

Dear Forum Members,

I would like to respond to Geoff Heaviside's query about microbicides

research in India, specifically 1) why volunteers for this study are

asked to use condoms, and 2) whether microbicides are being investigated

for rectal use.

There are multiple stages of research that every new drug or product

must go through before it can be approved for general use. First, a

substance must be proven safe and effective in laboratory and animal

studies. Then trials with humans can begin, in three escalating phases.

In Phase One trials of microbicides, a small number of healthy women

volunteer to use the experimental product for a short period of time- in

this case 14 days. Clinicians keep careful track of any effect the gel

may have for the women using it. If the gel proves to be safe in Phase

One- does not cause any harmful side effects for healthy women- then it

can move to Phase Two safety studies (enrolling a larger number of women

who use the gel for a longer period of time), and eventually to Phase

Three effectiveness studies designed to prove whether the microbicide

works to reduce transmission of HIV.

The NARI study described was a Phase One safety study, and its purpose

was to demonstrate the safety (absence of adverse side effects) of the

Pro-2000 gel when used by healthy women. Since the effectiveness of

Pro-2000 gel in preventing HIV transmission is still unknown, the women

who participated were counseled to use condoms in addition to the gel,

since condoms ARE known to prevent HIV when used consistently and

correctly.

The broader question - how can these trials demonstrate whether or not

microbicides actually work when participants are counseled to use

condoms-- is a frequent one. In Phase Three microbicide trials,

volunteers receive the best " package of prevention " currently known.

This includes ongoing counseling, condoms, and treatment of sexually

transmitted infections. Participants are also given the microbicide

(either the study gel or a placebo that looks exactly like the study gel

but without the active ingredient) and instructions on how to use it.

The women then keep track of when they have intercourse, whether they

use both a condom and the gel, a condom alone, the gel alone, or

nothing. Many women are unable to insist on condom use every single

time they have sex (if they could, we wouldn't need a microbicide so

badly!) The Phase Three trials enroll thousands of women, often in

several different countries, and collectively these volunteers

contribute enough information- based on their experience of using

different combinations of condom/microbicide/nothing- to demonstrate

whether the microbicide can reduce the risk of HIV transmission, either

when used together with a condom or when condoms aren't used.

Can microbicides prevent transmission of HIV through anal intercourse?

Early microbicides research was grounded in an effort to protect women-

who had no method within their own control to prevent sexual

transmission of HIV. The demographics of the epidemic have shown the

tragic consequences of this gap, with rates among women- particularly

young women- increasing exponentially over the last decade. Therefore,

the microbicides that are furthest along in development are being tested

for the prevention of vaginal transmission. Some of these products are

specifically designed vaginal use; others, however, are not and could

potentially be effective when used rectally. Initial research into

safety for rectal use is being done on some of the lead candidate

microbicides. Microbicides specifically designed for prevention of

penile-anal transmission are indeed on the scientific radar screen; more

advocacy will be required, however, to ensure that they progress through

the research process.

For more information and greater discussion of these topics and others,

I invite you to visit the Global Campaign for Microbicides website:

www.global-campaign.org. The Global Campaign is an advocacy coalition

promoting informed and active civil society engagement in the

microbicides research and development process. We have worked with

Indian NGO partners to educate the community and bring their

perspectives to issues of policy, research, and access to microbicides

and other prevention interventions in India.

Sincerely,

Gottemoeller

Global Campaign for Microbicides/PATH

1800 K Street NW, Suite 800

Washington DC 20006

Tel: 202 454 5039

Fax: 202 457 1466

E-mail: <mgottemoeller@...>