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

This study is currently recruiting participants.
Verified August 2013 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01473472
First received: November 8, 2011
Last updated: August 19, 2013
Last verified: August 2013

November 8, 2011
August 19, 2013
January 2012
December 2016   (final data collection date for primary outcome measure)
Contamination with HIV-1 or -2 [ Time Frame: From randomization to the end of the trial. The trial end date will be set by the scientific committee when the necessary number of primary endpoints has been reached without exceeding 4 years of follow-up. ] [ Designated as safety issue: No ]
The primary endpoint criteria is contamination with HIV-1 or -2, defined by the first diagnostic proof of infection: positive HIV serum test (using combined latest-generation tests HIV-1 + 2) or a positive test for HIV-1-RNA PCR in the plasma.
Contamination with HIV-1 or -2 [ Time Frame: From week-4 to the end of the trial. The trial end date will be set by the scientific committee when the necessary number of primary endpoints has been reached without exceeding 4 years of follow-up. ] [ Designated as safety issue: No ]
The primary endpoint criteria is contamination with HIV-1 or -2, defined by the first diagnostic proof of infection: positive HIV serum test (using combined latest-generation tests HIV-1 + 2) or a positive test for HIV-1-RNA PCR in the plasma.
Complete list of historical versions of study NCT01473472 on ClinicalTrials.gov Archive Site
  • Evolution of sexual behavior and potential at-risk behavior [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
    Self-questionnaires
  • Incidence of clinical and biological adverse events [ Time Frame: From randomization to the end of the trial, without exceeding 4 years of follow-up. ] [ Designated as safety issue: Yes ]
  • Treatment adherence [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
    Self-questionnaires, pill count. Drugs levels in plasma and hair (every 4 months).
  • Incidence of hepatitis B [ Time Frame: From randomization to the end of the trial, without exceeding 4 years of follow-up ] [ Designated as safety issue: No ]
  • Incidence of other sexually transmitted diseases [ Time Frame: From randomization to the end of the trial, without exceeding 4 years of follow-up ] [ Designated as safety issue: No ]
  • Frequency of HIV resistance to antiretrovirals in HIV infected subjects [ Time Frame: At the visit in the event of HIV infection ] [ Designated as safety issue: No ]
  • Emtricitabine and tenofovir concentrations in plasma, saliva and rectal samples. [ Time Frame: 0, 30 min, 1, 2, 4, 8 and 24 hours post-dose (2 tablets of Truvada) ] [ Designated as safety issue: No ]
    Ancillary study proposed between week-4 and the randomization - 12 volunteers. Blood and saliva samples at all time points and 2 sessions with rectal biopsies at two times for each volunteer (one before the drug is taken and one at one time after taking the 2 tablets)
  • Costs evaluation [ Time Frame: From randomization to the end of the trial, without exceeding 4 years of follow-up. ] [ Designated as safety issue: No ]

    Modelling to estimate an increase of years of life expectancy and of quality adjusted life year (QALY).

    Cost per avoided HIV contamination

  • Evolution of sexual behavior and potential at-risk behavior [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
    Self-questionnaires
  • Incidence of clinical and biological adverse events [ Time Frame: From week-4 to the end of the trial, without exceeding 4 years of follow-up. ] [ Designated as safety issue: Yes ]
  • Treatment adherence [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
    Self-questionnaires, pill count. Drugs levels in plasma and hair (every 4 months).
  • Incidence of hepatitis B [ Time Frame: From week-4 to the end of the trial, without exceeding 4 years of follow-up ] [ Designated as safety issue: No ]
  • Incidence of other sexually transmitted diseases [ Time Frame: From week-4 to the end of the trial, without exceeding 4 years of follow-up ] [ Designated as safety issue: No ]
  • Frequency of HIV resistance to antiretrovirals in HIV infected subjects [ Time Frame: At the visit in the event of HIV infection ] [ Designated as safety issue: No ]
  • Emtricitabine and tenofovir concentrations in plasma, saliva and rectal samples. [ Time Frame: 0, 30 min, 1, 2, 4, 8 and 24 hours post-dose (2 tablets of Truvada) ] [ Designated as safety issue: No ]
    Ancillary study proposed between week-4 and the randomization - 14 volunteers. Blood and saliva samples at all time points and 2 rectal biopsies at one time for each volunteer
  • Costs evaluation [ Time Frame: From week-4 to the end of the trial, without exceeding 4 years of follow-up. ] [ Designated as safety issue: No ]

    Modelling to estimate an increase of years of life expectancy and of quality adjusted life year (QALY).

    Cost per avoided HIV contamination

Not Provided
Not Provided
 
On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men
On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men

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, HBV and 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.

The trial will take place in two phases in order to ensure the general feasibility of the study:

  • a first enrollment phase for at least 300 participants
  • a second phase of 1600 additional participants.

The first phase of the trial will ensure the possibility for recruitment in France and Canada and to validate the tools put into place as part of the trial to enroll and follow participants. If the first phase is satisfactory, other sites will be progressively opened in Europe.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infection
  • Drug: Truvada
    2 tablets of truvada within 24 hours before first sexual relations, then 1 tablet of Truvada during the period of sexual activity including the last sexual intercourse, finally, a last dose of 1 tablet of Truvada approximately 24 hours later
    Other Name: tenofovir disoproxil and emtricitabine
  • Drug: Placebo
    2 tablets of placebo within 24 hours before first sexual relations, then 1 tablet of placebo every 24 hours during the period of sexual activity including the last sexual intercourse, finally, a last dose of 1 tablet of placebo approximatively 24 hours later
  • Active Comparator: Truvada
    associated with an overall offer of prevention (counselling, STD screening, condoms, HAV and HBV vaccinations, treatment post-exposure to the HIV infection)
    Intervention: Drug: Truvada
  • Placebo Comparator: Placebo of Truvada
    associated with an overall offer of prevention (counselling, STD screening, condoms, HAV and HBV vaccinations, treatment post-exposure to the HIV infection)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1900
December 2016
December 2016   (final data collection date for primary outcome measure)

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)
  • ALT < 2.5 ULN,
  • Neutrophil granulocytes ≥ 1 000/mm3, haemoglobin ≥ 10 g/dL, platelets ≥ 150 000/mm3
  • Negative HBs antigen and negative HCV serology (or negative HCV PCR if positive serology)
  • Agrees to be contacted personally, if possible by telephone, 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 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, corticosteroids 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.
Male
18 Years and older
Yes
Contact: Jean-Michel MOLINA, Professor 33.1.42.49.90.66 jean-michel.molina@sls.aphp.fr
Canada,   France
 
NCT01473472
2011-002645-35, IPERGAY
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Not Provided
Principal Investigator: Jean-Michel MOLINA, Professor Hôpital Saint-Louis Paris FRANCE
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP