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

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Truvada
Placebo
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring Prophylaxis, HIV infection, tenofovir, emtricitabine, men who have sex with men

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • CHUM - Hôpital Hôtel Dieu
  • Hôpital de La Croix Rousse
  • CHU Hôtel Dieu
  • Hôpital de l'Archet
  • Hôpital Saint-Louis
  • Hôpital Tenon
  • Hôpital Gustave Dron

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Truvada

Placebo of Truvada

Arm Description

associated with an overall offer of prevention (counselling, STD screening, condoms, HAV and HBV vaccinations, treatment post-exposure to the HIV infection)

associated with an overall offer of prevention (counselling, STD screening, condoms, HAV and HBV vaccinations, treatment post-exposure to the HIV infection)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evolution of sexual behavior and potential at-risk behavior
Self-questionnaires
Incidence of clinical and biological adverse events
Treatment adherence
Self-questionnaires, pill count. Drugs levels in plasma and hair (every 4 months).
Incidence of hepatitis B
Incidence of other sexually transmitted diseases
Frequency of HIV resistance to antiretrovirals in HIV infected subjects
Genotype
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)
Costs evaluation
Modelling to estimate an increase of years of life expectancy and of quality adjusted life year (QALY). Cost per avoided HIV contamination

Full Information

First Posted
November 8, 2011
Last Updated
May 10, 2017
Sponsor
ANRS, Emerging Infectious Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT01473472
Brief Title
On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men
Acronym
IPERGAY
Official Title
On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
Prophylaxis, HIV infection, tenofovir, emtricitabine, men who have sex with men

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Truvada
Arm Type
Active Comparator
Arm Description
associated with an overall offer of prevention (counselling, STD screening, condoms, HAV and HBV vaccinations, treatment post-exposure to the HIV infection)
Arm Title
Placebo of Truvada
Arm Type
Placebo Comparator
Arm Description
associated with an overall offer of prevention (counselling, STD screening, condoms, HAV and HBV vaccinations, treatment post-exposure to the HIV infection)
Intervention Type
Drug
Intervention Name(s)
Truvada
Other Intervention Name(s)
tenofovir disoproxil and emtricitabine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Contamination with HIV-1 or -2
Description
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.
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.
Secondary Outcome Measure Information:
Title
Evolution of sexual behavior and potential at-risk behavior
Description
Self-questionnaires
Time Frame
Every 2 months without exceeding 5 years of follow-up.
Title
Incidence of clinical and biological adverse events
Time Frame
From randomization to the end of the trial, without exceeding 5 years of follow-up.
Title
Treatment adherence
Description
Self-questionnaires, pill count. Drugs levels in plasma and hair (every 4 months).
Time Frame
Every 2 months without exceeding 5 years of follow-up.
Title
Incidence of hepatitis B
Time Frame
From randomization to the end of the trial, without exceeding 5 years of follow-up
Title
Incidence of other sexually transmitted diseases
Time Frame
From randomization to the end of the trial, without exceeding 5 years of follow-up
Title
Frequency of HIV resistance to antiretrovirals in HIV infected subjects
Description
Genotype
Time Frame
At a visit as soon as the HIV infection is diagnosed
Title
Emtricitabine and tenofovir concentrations in plasma, saliva and rectal samples.
Description
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)
Time Frame
0, 30 min, 1, 2, 4, 8 and 24 hours post-dose (2 tablets of Truvada)
Title
Costs evaluation
Description
Modelling to estimate an increase of years of life expectancy and of quality adjusted life year (QALY). Cost per avoided HIV contamination
Time Frame
From randomization to the end of the trial, without exceeding 5 years of follow-up.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel MOLINA, Professor
Organizational Affiliation
Hôpital Saint-Louis Paris FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUM - Hôpital Hôtel Dieu
City
Montréal
Country
Canada
Facility Name
Hôpital de La Croix Rousse
City
Lyon
Country
France
Facility Name
CHU Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital de l'Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75
Country
France
Facility Name
Hôpital Gustave Dron
City
Tourcoing
ZIP/Postal Code
59208
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31784343
Citation
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.
Results Reference
derived
PubMed Identifier
29229440
Citation
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.
Results Reference
derived
PubMed Identifier
28747274
Citation
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.
Results Reference
derived
PubMed Identifier
26624850
Citation
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.
Results Reference
derived
Links:
URL
http://www.anrs.fr
Description
sponsor of the study

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

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