Participant follow-up resumed in FHI's oral Tenofovir study in Cameroon

February 22, 2005 —

RESEARCH TRIANGLE PARK, NC — Family Health International (FHI) is conducting a study in Cameroon to see if a widely used HIV treatment drug, called tenofovir, or TDF, can also safely prevent HIV in women who are at high risk of acquiring the infection. Similar trials are occurring in other parts of the world, including the United States and Asia.

On February 3, 2005, the Ministry of Public Health of Cameroon temporarily suspended FHI's clinical trial of tenofovir, pending discussion and action on a number of recommendations from a recent Ministry evaluation of the study. On February 14, the Ministry determined that follow-up of study participants who have already been enrolled in the trial could continue while FHI works to comply with these recommendations. This decision will help ensure the health and well-being of the women who have volunteered to take part in this important study.

The safety and welfare of study participants is FHI's highest priority. The Ministry's decision allows us to continue without interruption to monitor their HIV status, as well as other aspects of their health, such as kidney and liver function. Such continued monitoring during periods of clinical trial suspension is in compliance with both U.S. and European regulations and is, we believe, the medically and ethically responsible thing to do.

FHI is committed to addressing all concerns identified in the Ministry's careful review of the tenofovir study and has already made significant progress in doing so. These recommendations include revising administrative procedures — such as the distribution of quarterly reports — and augmenting local partnerships with HIV/AIDS prevention and control associations in prevention counseling and support for participants who become HIV-infected during the trial. We are working with our local partners to address remaining, primarily administrative issues.

FHI is committed to the oral tenofovir trial. Resuming the study as soon as possible is extremely important. This prevention approach could have an especially important impact in Africa, where more than 70 percent of all HIV infections occur, and would be of particular benefit to women, who often have difficulty negotiating condom use.