PrEP Trial Design and Ethical Considerations

April 30, 2013

In January AVAC collaborated with the French AIDS organization Sidaction to host a meeting, Challenges of clinical trial design, degree of evidence and recommendations in the era of PrEP. The meeting provided a forum for local French researchers and advocates to discuss IPERGAY, the intermittent PrEP study currently underway with men who have sex with men in France. A number of international researchers, advocates and normative agencies were also on hand to broaden the discussion. Advocates on both sides of the Atlantic have questioned the use of a placebo arm in IPERGAY since the US FDA approved daily TDF/FTC (Truvada) for prevention last July. French and other European regulators, however, have yet to approve the use of Truvada as PrEP, therefore it is not currently available for prevention, only treatment.

The daylong gathering brought key stakeholders together to discuss the difficult questions of trial design and ethics—issues relevant not only to IPERGAY but to other current and future biomedical prevention trials. Presentations from the meeting are available at

While participants in the meeting highlighted the various perspectives on the actual IPERGAY trial design, there was general agreement on the important role of the trial in answering questions around intermittent PrEP, whether TDF/FTC could be taken “on demand”, meaning at the time of sex, and still reduce the risk of HIV transmission.

At the meeting the French organization AIDES called on the French regulatory agency (the National Security Agency of Medicines and Health Products, or MSNA) to approve Truvada via a compassionate use authorization for HIV prevention among most at-risk groups. For a copy of the press release, click here.

Continue following developments at