Status:
COMPLETED
On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Conditions:
HIV Infection
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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" antiretrovir...
Detailed Description
The trial has been taken place in two phases in order to ensure the general feasibility of the study: * a first enrollment phase for at least 300 participants to ensure the possibility for recruitmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2016
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01473472
Start Date
January 1 2012
End Date
December 15 2016
Last Update
May 11 2017
Active Locations (7)
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1
CHUM - Hôpital Hôtel Dieu
Montreal, Canada
2
Hôpital de La Croix Rousse
Lyon, France
3
CHU Hôtel Dieu
Nantes, France, 44093
4
Hôpital de l'Archet
Nice, France, 06202