A Family Health International study assessing the viability of Gilead’s nucleotide analogue, tenofovir (Viread) to prevent HIV infection in women at high risk of sexually acquiring the virus has been suspended in the port city of Douala, Cameroon, in West Africa. The research is being supported by a US$6.5 million grant awarded to Family Health International in 2002 by the Bill & Melinda Gates Foundation.
Cameroon Health Minister, Urbain Olanguena Awono, claims “dysfunctions” were found by a Cameroonian Health Ministry audit commission who visited the study site on February 3rd. "The suspension will remain effective until the promoter of the trial shows proof that the commitments made in their agreement are rigourously respected and all the conditions of their effective implementation are satisfactory," he said in a statement released the same day and reported by the news agency, the Associated Foreign Press (AFP).
In response, Family Health International’s President Ward Cates, who met Olanguena Awono last week to discuss the trial’s future, told the state run Cameroon Tribune that “there is nothing dangerous about the trial conducted at Douala.” The study’s co-ordinator, Professor Anderson Doh Sama, told news agency IRIN that the trial, which began in June 2004, and was planned to last 12 months, had been halted due to administrative problems. "The clinical trial will resume as soon as possible because we have been in constant discussion with the [government health representative] who knows and monitors all that we are doing," he said.
The audit commission visit was prompted by a French-made documentary that aired on French television last month, alleging that the 400 commercial sex workers who were participating in the trial were not sufficiently informed of the risks involved. A press release from FHI issued after the documentary aired, claims that it was “a biased report” and that “a detailed informed consent process,” took place, “to ensure that volunteers understand all risks and benefits of trial participation and know that they are not obligated to participate and can stop participating at any time.” However, activists claim that the consent forms were written in English, and that the majority of participants’ first language was French.
The TV programme also alleged that healthcare provisions for women who became infected during the course of the trial were inadequate. According to a Family Health International press release, the study staff would help the women “assess (sic) the best local care and support services, including antiretroviral drugs when necessary.” However, although all study participants are remunerated an unspecified amount for their time and travel to the study site, no financial aid or free drugs would be made available for the women who tested positive during the study. Instead, the study staff would help in “identifying potential resources to help defray health care or other referral costs.”
Family Health International are in the final stages of seeking approval for a second study for the women who become HIV-infected during the tenofovir pre-exposure prophylaxis (PREP) study. “Although seroconverters already have access to standard care available in the country, this second study would give them access to state-of-the art diagnosis and care for HIV-infected people for up to 36 months, with the possibility of extension, and will help further assess the role of tenofovir within other HIV prevention and care strategies,” says a Family Health International press release.
Family Health International, a research and service organisation based in Research Triangle Park, North Carolina, was prevented from conducting a large-scale tenofovir PREP study in Cambodia last year, reported on aidsmap here, although similar studies are continuing in Ibadan, Nigeria, and Tema, Ghana. A study examining tenofovir as PREP in high-risk gay men, is also continuing in the US cities of Atlanta and San Francisco.