The ANRS (French National Agency for Research on AIDS and Viral Hepatitis) is about to launch in Europe the first pre-HIV exposure prevention trial in men who have sex with men.
This phase III trial—ANRS IPERGAY—will start at the end of January 2012, in Paris (Hôpital Saint-Louis, Professor Jean-Michel Molina and Hôpital Tenon, Professor Gilles Pialoux) and Lyon (Hôpital de la Croix-Rousse, Dr Laurent Cotte), and later in Montreal in Quebec (CHUM Hôpital Hôtel Dieu, Dr Cécile Tremblay). The trial will include 300 volunteers in the pilot phase and ultimately 1900 in total.
ANRS IPERGAY will involve men who have sex with men and seronegative trans men who have anal sex with men without routine use of condoms, with at least two different sexual partners in the six months prior to trial participation. Participation will last for between 12 (minimum) and 48 (maximum) months.
The trial will compare two groups of participants, one given Truvada®, the other a placebo, taken in both cases during the period of sexual activity, starting before sexual relations and ending afterwards.
All participants, irrespective of group, will be offered various means of prevention: free condoms, regular HIV screening, regular screening for and treatment of sexually transmitted diseases, vaccination against hepatitis A and B. Participants can ask for personalized prevention advice, if they wish.
An important part of the trial will involve a social sciences study of the profiles of participants and analysis of their sexual behavior, in particular regarding condom use, and will determine whether or not they take the medication as intended.
Participants will be invited to the hospital every two months or so for an interview and for clinical examinations, including screening tests.
The ANRS will sponsor and fund the trial, and Gilead will supply the medication.
The HIV community-based association Aides helped draw up the protocol, is a scientific and operations partner in the trial, and is a member of the scientific board. It will coordinate recruitment in the field and provide volunteers with prevention support.
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