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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
HIV Infection
Drug: Truvada
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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



Estimated Enrollment: 1900
Study Start Date: January 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
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)
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473472

Contacts
Contact: Jean-Michel MOLINA, Professor 33.1.42.49.90.66 jean-michel.molina@sls.aphp.fr

Locations
Canada
CHUM - Hôpital Hôtel Dieu Recruiting
Montréal, Canada
Contact: Pascale Arlotto       pascale.arlotto.chum@ssss.gouv.qc.ca   
Principal Investigator: Cécile Tremblay, Dr         
France
Hôpital de La Croix Rousse Recruiting
Lyon, France
Contact: Laurent Cotte, PH         
Principal Investigator: Laurent Cotte, PH         
CHU Hôtel Dieu Recruiting
Nantes, France, 44093
Contact: Benedicte Bonnet, MD    33 2 40 08 33 69    benedicte.bonnet@chu-nantes.fr   
Contact: Michel Besnier, MD    33 2 40 08 33 69    michel.besnier@chu-nantes.fr   
Principal Investigator: Francois Raffi, Professor         
Hôpital de l'Archet Recruiting
Nice, France, 06202
Contact: Sophie Breaud       breaud.s@chu-nice.fr   
Contact: Aline Joulie       joulie.a@chu-nice.fr   
Principal Investigator: Eric Cua, PH         
Hôpital Tenon Recruiting
Paris, France, 75
Contact: Gilles Pialoux         
Principal Investigator: Gilles Pialoux, Professor         
Hôpital Saint-Louis Recruiting
Paris Cedex 10, France, 75475
Principal Investigator: Jean-Michel MOLINA, Professor         
Hôpital Gustave Dron Recruiting
Tourcoing, France, 59208
Contact: Antoine Cheret, PH       antoine.cheret@ch-tourcoing.fr   
Principal Investigator: Antoine Cheret, PH         
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
Principal Investigator: Jean-Michel MOLINA, Professor Hôpital Saint-Louis Paris FRANCE
  More Information

Additional Information:
No publications provided

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     History of Changes
Other Study ID Numbers: 2011-002645-35, IPERGAY
Study First Received: November 8, 2011
Last Updated: August 19, 2013
Health Authority: France: National Agency for the Safety of Medicine and Health Products

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Prophylaxis
HIV infection
tenofovir
emtricitabine
men who have sex with men

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Immune System Diseases
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Anti-HIV Agents
Infection
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Emtricitabine
Tenofovir disoproxil
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014