Wall Street Journal - February 8, 2005
Marilyn Chase at marilyn.chase@wsj.com

Prospects for AIDS prevention-in-a-pill have captured scientific and public interest because a vaccine is thought to be at least a decade away. The study's results originally were expected to come as early as next year. It's unknown how long this site shutdown could delay answers; the study is proceeding so far at other African sites.

Family Health International, a nonprofit public-health organization based in Research Triangle Park, N.C., is conducting the study under a grant from the Bill and Melinda Gates Foundation. Gilead Sciences Inc. is supplying the AIDS antiviral drug Viread, which also is known as tenofovir, free for the study.

The halt to the Cameroon study follows the shutdown of a similar study site in Cambodia last summer after demonstrations by the same group, Act Up Paris, against Gilead.

Ward Cates, president of FHI's Institute for Family Health, flew to Cameroon yesterday to try to salvage the trial. Previously the study was cleared by Cameroon's National Ethics Committee, as well as FHI's review board.

The study was already under way, involving 400 women -- many of them prostitutes at high risk of contracting the deadly AIDS virus. Half were randomly assigned to receive a daily dose of tenofovir and half a placebo pill. Participants were to receive monthly health exams, including checks of their liver and kidney functions to rule out drug toxicity.

All of the women gave informed consent and were counseled about safe sex in the presence of a bilingual or trilingual patient advocate, Dr. Cates said. Anyone who became infected during the course of the trial was to be referred to one of Cameroon's AIDS treatment programs for antiviral drugs.

Act Up Paris denounced these arrangements as inadequate, alleging that the volunteers were "utilized as veritable guinea pigs" in a cynical attempt to promote the drug's commercial prospects.

Dr. Cates denied the accusation by Act Up Paris that the study was unethical, saying, "many of [their] insinuations were just wrong." He added, "My concern is that suspension of the trial might mean closing the doors of the clinic," denying volunteers access to counseling, checkups and condoms.

In Foster City, Calif., Gilead Sciences said it has pledged to make Viread -- already an approved AIDS treatment -- available at cost to resource-poor countries. Thus, Gilead said it won't make any profit from the drug's use as a preventative in these countries, even if the study succeeds.

"It's our hope that the study will continue," a company spokeswoman said.

American AIDS activist Mark Harrington, director of the New York-based Treatment Action Group, charged Act Up Paris with "ethical imperialism" in scuttling the trial.

"It's not going to reduce HIV to stop this trial, or provide health care to a single one of those sex workers in Cameroon," said Mr. Harrington. Although FHI could improve its communication with volunteers, he added that stopping the trial "could delay discovery of a powerful prevention tool -- if we could ever find out it works."

The halted study was part of a $6.5 million Gates Foundation grant to FHI to test the drug in people at high risk for AIDS in five countries: Ghana, Nigeria, Malawi, and the now-canceled Cambodia and Cameroon sites.

Several studies of tenofovir eventually will embrace a number of groups at high risk including prostitutes, heterosexual men in Africa and intravenous drug users. A separate study sponsored by the U.S. Centers for Disease Control and Prevention is examining the safety of tenofovir prevention in U.S. gay men in Atlanta and San Francisco.

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