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| ID | Type | Description | Link |
|---|---|---|---|
| IPERGAY | Other Identifier | ANRS |
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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.
The trial has been taken place in two phases in order to ensure the general feasibility of the study:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Truvada | Active Comparator | associated with an overall offer of prevention (counselling, STD screening, condoms, HAV and HBV vaccinations, treatment post-exposure to the HIV infection) |
|
| Placebo of Truvada | Placebo Comparator | associated with an overall offer of prevention (counselling, STD screening, condoms, HAV and HBV vaccinations, treatment post-exposure to the HIV infection) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Truvada | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Contamination with HIV-1 or -2 | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of sexual behavior and potential at-risk behavior | Self-questionnaires | Every 2 months without exceeding 5 years of follow-up. |
| Incidence of clinical and biological adverse events | From randomization to the end of the trial, without exceeding 5 years of follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Michel MOLINA, Professor | Hôpital Saint-Louis Paris FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUM - Hôpital Hôtel Dieu | Montreal | Canada | ||||
| Hôpital de La Croix Rousse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39100527 | Derived | Chawki S, Leturque N, Minier M, Gabassi A, Foubert V, Charreau I, Cua E, Pialoux G, Meyer L, Molina JM, Delaugerre C. Prevalence and Risk Factors of Cytomegalovirus Among Men Having Sex With Men Enrolled in a Pre-Exposure Prophylaxis Study. Open Forum Infect Dis. 2024 Jul 18;11(8):ofae400. doi: 10.1093/ofid/ofae400. eCollection 2024 Aug. | |
| 31784343 |
| Label | URL |
|---|---|
| sponsor of the study | View source |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | 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 |
|
| Treatment adherence | Self-questionnaires, pill count. Drugs levels in plasma and hair (every 4 months). | Every 2 months without exceeding 5 years of follow-up. |
| Incidence of hepatitis B | From randomization to the end of the trial, without exceeding 5 years of follow-up |
| Incidence of other sexually transmitted diseases | From randomization to the end of the trial, without exceeding 5 years of follow-up |
| Frequency of HIV resistance to antiretrovirals in HIV infected subjects | Genotype | At a visit as soon as the HIV infection is diagnosed |
| Emtricitabine and tenofovir concentrations in plasma, saliva and rectal samples. | 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) | 0, 30 min, 1, 2, 4, 8 and 24 hours post-dose (2 tablets of Truvada) |
| Costs evaluation | 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. |
| Lyon |
| France |
| CHU Hôtel Dieu | Nantes | 44093 | France |
| Hôpital de l'Archet | Nice | 06202 | France |
| Hôpital Saint-Louis | Paris | 75475 | France |
| Hôpital Tenon | Paris | 75 | France |
| Hôpital Gustave Dron | Tourcoing | 59208 | France |
| 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. |
| 29229440 | Derived | 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. |
| 28747274 | Derived | 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. |
| 26624850 | Derived | 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. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D000068679 |
| Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |