NCT01473472

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" 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_3

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2016

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

4.5 years

First QC Date

November 8, 2011

Last Update Submit

May 10, 2017

Conditions

HIV Infection

Keywords

ProphylaxisHIV infectiontenofoviremtricitabinemen who have sex with men

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (8)

  • Evolution of sexual behavior and potential at-risk behavior

    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.

  • Treatment adherence

    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

  • +3 more secondary outcomes

Study Arms (2)

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)

Drug: Truvada

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)

Drug: Placebo

Interventions

TruvadaDRUG

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

Also known as: tenofovir disoproxil and emtricitabine
Truvada
PlaceboDRUG

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

Placebo of Truvada

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHUM - Hôpital Hôtel Dieu

Montreal, Canada

Location

Hôpital de La Croix Rousse

Lyon, France

Location

CHU Hôtel Dieu

Nantes, 44093, France

Location

Hôpital de l'Archet

Nice, 06202, France

Location

Hôpital Saint-Louis

Paris, 75475, France

Location

Hôpital Tenon

Paris, 75, France

Location

Hôpital Gustave Dron

Tourcoing, 59208, France

Location

Related Publications (5)

  • 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.

    PMID: 39100527DERIVED

  • 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.

    PMID: 31784343DERIVED

  • 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.

    PMID: 29229440DERIVED

  • 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.

    PMID: 28747274DERIVED

  • 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.

    PMID: 26624850DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsHomosexuality

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexualitySexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

TenofovirOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsEmtricitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Jean-Michel MOLINA, Professor

    Hôpital Saint-Louis Paris FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2011

First Posted

November 17, 2011

Study Start

January 1, 2012

Primary Completion

June 30, 2016

Study Completion

December 15, 2016

Last Updated

May 11, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)FR(6)