FHI ends clinical trial of ARV drug Tenofovir

A US-based research organisation has announced that it will end the controversial testing of the anti-AIDS drug, Tenofovir, on sex workers in Cameroon. In a statement Family Health International (FHI) said, "Over the next month, women will return to the clinic for their final visits. By the end of September 2005, the site will be closed." Tenofovir is an antiretroviral (ARV) drug manufactured by US pharmaceutical company Gilead and sold under the brand name 'Viread' for the past three years. "FHI will ensure that the five women who have become HIV-infected while enrolled in the tenofovir study in Cameroon will have long-term access to HIV/AIDS state-of-the-art care and treatment, as defined by the Cameroon National AIDS Control Programme," the organisation confirmed. Clinical trials were suspended five months ago after health authorities questioned the manner in which the tests were being conducted. In January, Cameroon's Reseau Ethique Droit et Sida (REDS), a network of ethics, rights and HIV/AIDS organisations, and Act Up-Paris, a French association of AIDS activists, slammed the tests for failing to provide the 400 study participants with adequate information on the risks they would be facing, as well as the lack of ARVs for patients infected during the trials. "We are not opposed to clinical studies - on the contrary, this trial was legitimate, since this molecule could actually prevent HIV-infection. But we don't want trials that don't comply with ethical rules applied in the West," said Regis Samba-Koundzi, head of Act-up's North/South commission. "We question the methodology: the lack of treatment available for participants who became HIV-infected during the trial; the lack of promotion of methods of contraception for women, such as Femidom [a female condom], which could have allowed participants to practice safe sex, Samba-Koundzi told PlusNews. "If they can't meet our demands, they'd better close the trial." Clinical trials have been conducted in Cameroon since September 2004, and involved 400 sex workers divided into two groups, one taking a Tenofovir pill every day and the other taking a placebo. At the end of the trials, all the women were again tested for HIV. Despite a substantial decrease in the price of ARVs, most patients still can't afford roughly US $8 a month for treatment. According to the United Nations, 51 percent of the population lives on less than US $2 a day. OPENING A DEBATE ON ETHICS FHI noted in its statement that "this important international issue - how to access long-term HIV treatment for participants in research - is still being discussed by international and national agencies ... including ... UNAIDS in Geneva". Act-Up's Samba-Koundzi agreed. "Since the suspension of the clinical trial in Cameroon, large NGO networks are discussing this issue and the way to conduct trials in developing countries." He pointed out that Gilead had already been forced to scrap trials of Tenofovir in Cambodia, where a similar row over ethics occurred. The Phnom Penh authorities suspended the trial in 2004, after the Cambodian participants complained about the way it was carried out. FHI subsequently cancelled an impending study in Nigeria, according to Marie de Cenival of French NGO, Sidaction, who praised the crucial role of activists in FHI's decision. "The activists in Nigeria are very well informed - it all started with them," she said during a telephone call from Paris. A recent report released by the Nigeria HIV Vaccine and Microbicide Advocacy Group (NHVMAG), a group of NGOs, insisted on the need for broad-based debate on clinical trial ethics. "The lessons learnt from the trial in Nigeria would feed into processes for developing and implementing future research protocols. One of the highlights of the recommendations include the need for future research processes to focus on ensuring partnership with all stakeholders throughout the research process," the report noted. Samba-Koundzi urged local associations to "stay alert", remarking that "nobody speaks out - we often don't know what happens on the ground; we are raising awareness among activists so that they'll keep an eye out". FHI announced that similar clinical trials were being conducted in Ghana, the United States, Thailand and Botswana, at a cost of US $6.5 million, funded by the Bill and Melinda Gates foundation. Another trial is to be conducted in Malawi. In Cameroon, "safety data on use of oral tenofovir for HIV prevention had been obtained ... [which] will be combined with data from the other sites to answer questions on this potential HIV prevention drug", according to FHI. However, FHI also noted that "so much time has elapsed, with participants not being able to receive the study drug, that the data will not be able to determine the effectiveness of tenofovir in preventing HIV acquisition".