On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men

• Status: Completed
• Trial end date: 2016-12-15
• Target enrollment: 0
• Participant gender: Male

Summary

This phase III, multi-centre, comparative, double-blind, randomized trial on 2 parallel groups is designed to evaluate a strategy for the prevention of HIV infection including "on demand" antiretroviral pre-exposure with Truvada versus placebo, associated with overall prevention (counselling, condoms, sexually transmitted diseases (STD) screening, hepatitis B virus (HBV) and hepatitis A virus (HAV) vaccinations and post-exposure treatment of HIV infection) in men who have sex with men (MSM), exposed to the risk of HIV infection. Indeed recent studies have reported a higher incidence of new HIV infection in MSM as compared to the general population, new approaches to the prevention of HIV infection are, therefore, necessary in order to consider the limits of current strategies.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• Age ≥ 18 years old

• Male (or transgender) having sex with men

• Not infected with HIV-1 or HIV-2

• Elevated risk of HIV contamination : anal sexual relations with at least 2 different sexual partners within the past 6 months without the systematic use of a condom

• Satisfactory kidney function with a clearance of more than 60 mL/min (Cockcroft formula)

• Alanine aminotransferase (ALT) < 2.5 Upper Limit of Normal (ULN),

• Neutrophil granulocytes ≥ 1 000/mm3, haemoglobin ≥ 10 g/dL, platelets ≥ 150 000/mm3

• Negative HBs antigen and negative hepatitis C virus (HCV) serology (or negative HCV PCR if positive serology)

• Agrees to be contacted personally, if possible by telephone, short message system (SMS) or e-mail

• Agrees to the constraints imposed by the trial (visits every 2 months)

• Subjects enrolled in or a beneficiary of a Social Security program (State Medical Aid or Aide médicale de l'Etat (AME) is not a Social Security program).

• Signature of the informed consent form.

Exclusion Criteria:

• Subject in a stable and exclusive relationship with a person

• Systematic use of a condom during sexual relations

• Expected to go abroad for more than 3 consecutive months or move expected to a city where the study is not being conducted.

• Presence of significant glycosuria or proteinuria > 1+ in the urine dipstick, in the absence of infection.

• Presence of significant haematuria or leukocyturia > 2+ in the urine dipstick, in the absence of infection.

• History of chronic kidney disease, osteoporosis, osteopaenia

• History of pathological bone fracture not related to trauma

• Treatment with Interferon, Interleukin, or antiretrovirals

• Treatment that could inhibit or compete with the tubular secretion of antiretrovirals

• Treatment undergoing investigation

• Intravenous toxicomania

• Subject who is currently receiving or going to receive a potentially nephrotoxic treatment (long-term anti-inflammatory)

• Gastro-intestinal disease (or chronic nausea or vomiting) disrupting the absorption of treatments

• Positive HBs antigen

• Positive HCV serology with positive HCV PCR

• Life-threatening disease (lymphoma) or other serious disease (cardiovascular, renal, pulmonary, unstable diabetes) that could require treatment that could disrupt adherence to the treatment

• Subject potentially non-compliant.