- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01473472
On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men (IPERGAY)
Study Overview
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 recruitment in France and Canada and to validate the tools put into place as part of the trial to enroll and follow participants
- a second phase of 1600 additional participants. This extension phase started on July 2014.
The recruitment has been suspended following the recommendations of Data Safety and Monitoring Board (DSMB): the placebo arm has been stopped and Truvada was available for all the participants of the trial since November 2014. The initial protocol was amended and 361 participants were enrolled in the open-label phase. Sub-studies were proposed to the participants:
- Sub-study on the outcome of participants receiving sofosbuvir/ledipasvir treatment for recent HCV infection (protocol amendment on April 2015)
- Randomized sub-study to evaluate the efficacy of doxycycline post-exposure prophylaxis on sexually transmitted infections (protocol amendment on July 2015)
- Sub-study to evaluate Truvada adherence with Medication Event Monitoring System (MEMS) (protocol amendment on December 2015)
- Sub-study on drugs use and the impact on sexual behavior and Truvada adherence (protocol amendment on December 2015).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Montréal, Canada
- CHUM - Hôpital Hôtel Dieu
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Lyon, France
- Hopital de la Croix Rousse
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Nantes, France, 44093
- Chu Hotel Dieu
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Nice, France, 06202
- Hopital de l'Archet
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Paris, France, 75
- Hopital Tenon
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Paris Cedex 10, France, 75475
- Hôpital Saint-Louis
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Tourcoing, France, 59208
- Hôpital Gustave Dron
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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)
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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 Names:
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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)
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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 5 years of follow-up.
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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 Polymerase Chain Reaction (PCR) in the plasma.
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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 5 years of follow-up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Evolution of sexual behavior and potential at-risk behavior
Time Frame: Every 2 months without exceeding 5 years of follow-up.
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Self-questionnaires
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Every 2 months without exceeding 5 years of follow-up.
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Incidence of clinical and biological adverse events
Time Frame: From randomization to the end of the trial, without exceeding 5 years of follow-up.
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From randomization to the end of the trial, without exceeding 5 years of follow-up.
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Treatment adherence
Time Frame: Every 2 months without exceeding 5 years of follow-up.
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Self-questionnaires, pill count.
Drugs levels in plasma and hair (every 4 months).
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Every 2 months without exceeding 5 years of follow-up.
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Incidence of hepatitis B
Time Frame: From randomization to the end of the trial, without exceeding 5 years of follow-up
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From randomization to the end of the trial, without exceeding 5 years of follow-up
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Incidence of other sexually transmitted diseases
Time Frame: From randomization to the end of the trial, without exceeding 5 years of follow-up
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From randomization to the end of the trial, without exceeding 5 years of follow-up
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Frequency of HIV resistance to antiretrovirals in HIV infected subjects
Time Frame: At a visit as soon as the HIV infection is diagnosed
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Genotype
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At a visit as soon as the HIV infection is diagnosed
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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)
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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)
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0, 30 min, 1, 2, 4, 8 and 24 hours post-dose (2 tablets of Truvada)
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Costs evaluation
Time Frame: From randomization to the end of the trial, without exceeding 5 years of follow-up.
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Modelling to estimate an increase of years of life expectancy and of quality adjusted life year (QALY). Cost per avoided HIV contamination |
From randomization to the end of the trial, without exceeding 5 years of follow-up.
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Collaborators and Investigators
Investigators
- Principal Investigator: Jean-Michel MOLINA, Professor, Hôpital Saint-Louis Paris FRANCE
Publications and helpful links
General Publications
- Antoni G, Tremblay C, Delaugerre C, Charreau I, Cua E, Rojas Castro D, Raffi F, Chas J, Huleux T, Spire B, Capitant C, Cotte L, Meyer L, Molina JM; ANRS IPERGAY study group. On-demand pre-exposure prophylaxis with tenofovir disoproxil fumarate plus emtricitabine among men who have sex with men with less frequent sexual intercourse: a post-hoc analysis of the ANRS IPERGAY trial. Lancet HIV. 2020 Feb;7(2):e113-e120. doi: 10.1016/S2352-3018(19)30341-8. Epub 2019 Nov 26.
- Molina JM, Charreau I, Chidiac C, Pialoux G, Cua E, Delaugerre C, Capitant C, Rojas-Castro D, Fonsart J, Bercot B, Bebear C, Cotte L, Robineau O, Raffi F, Charbonneau P, Aslan A, Chas J, Niedbalski L, Spire B, Sagaon-Teyssier L, Carette D, Mestre SL, Dore V, Meyer L; ANRS IPERGAY Study Group. Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex with men: an open-label randomised substudy of the ANRS IPERGAY trial. Lancet Infect Dis. 2018 Mar;18(3):308-317. doi: 10.1016/S1473-3099(17)30725-9. Epub 2017 Dec 8.
- Molina JM, Charreau I, Spire B, Cotte L, Chas J, Capitant C, Tremblay C, Rojas-Castro D, Cua E, Pasquet A, Bernaud C, Pintado C, Delaugerre C, Sagaon-Teyssier L, Mestre SL, Chidiac C, Pialoux G, Ponscarme D, Fonsart J, Thompson D, Wainberg MA, Dore V, Meyer L; ANRS IPERGAY Study Group. Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study. Lancet HIV. 2017 Sep;4(9):e402-e410. doi: 10.1016/S2352-3018(17)30089-9. Epub 2017 Jul 23.
- Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A, Raffi F, Pintado C, Chidiac C, Chas J, Charbonneau P, Delaugerre C, Suzan-Monti M, Loze B, Fonsart J, Peytavin G, Cheret A, Timsit J, Girard G, Lorente N, Preau M, Rooney JF, Wainberg MA, Thompson D, Rozenbaum W, Dore V, Marchand L, Simon MC, Etien N, Aboulker JP, Meyer L, Delfraissy JF; ANRS IPERGAY Study Group. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46. doi: 10.1056/NEJMoa1506273. Epub 2015 Dec 1.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
- Emtricitabine
- Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Other Study ID Numbers
- 2011-002645-35
- IPERGAY (Other Identifier: ANRS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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