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Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France. (SimpPrEP)

Primary Purpose

HIV/AIDS

Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TDF/FTC 300mg/200mg fixed-dose combination tablets
TAF/FTC 25mg/200mg fixed-dose combination tablets
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring PrEP exposure prophylaxis (PrEP), On-demand, Event-driven, TAF

Eligibility Criteria

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

Inclusion Criteria: Male at birth age ≥ 18 years old Reporting having sex with men Negative 4th generation HIV-1 and HIV-2 test Reporting condomless anal sex with men not more often than two days during the previous month and able to plan their sexual activity Risk of HIV acquisition based on self-report of at least one of the following behaviors during the 6 months before enrollment: condomless anal sex with at least 2 different sexual partners, sexually transmitted infection (rectal chlamydia and/or rectal gonorrhea and/or syphilis), provided or received money goods or favor in exchange of sex, binge drinking or use of non-injectable recreational drugs. Consenting to participate and agreeing to follow the clinical trial procedures, including adherence to study visits every 3 months In France: Person affiliated with or benefiting from a social security system (article L1121-11of the public health code in France) Non-inclusion criteria: Women and trans women Taking feminizing hormone therapy Positive HIV test result at screening or enrollment even if HIV infection is not confirmed Positive hepatitis B surface antigen test ALT or AST > 4 ULN Estimated glomerular filtration rate < 60mL/min/1.73m² History of chronic kidney disease, osteoporosis, osteopenia or pathological fracture not related to trauma Hypersensitivity to the study products F/TDF or F/TAF Past or concurrent participation in a HIV vaccine trial or concurrent participation in another clinical trial without the agreement of the principal investigators of the two trials Use of intravenous drugs within the last 12 months Person under legal guardianship Not likely to comply with the clinical trial procedures or with any condition incompatible with study participation, upon the investigator's judgement. Ongoing Post-Exposure Prophylaxis (PEP) for HIV

Sites / Locations

  • AP-HP - Hôpital Saint-Louis
  • STIs Clinic of the Office of Disease Prevention and Control Region 1

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Event-driven PrEP with TDF/FTC

Event-driven PrEP with TAF/FTC

Arm Description

Participants randomly assigned to the event-driven TDF/FTC arm will be instructed to take a loading dose of two single tablets containing coformulated TDF/FTC (300/200mg) 2 to 24 hours before sexual intercourse, followed by a third pill 24 hours after the first drug intake and a fourth pill 24 hours later. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse, then to take the two post-exposure pills.

Participants randomly assigned to the event-driven TAF/FTC arm will be instructed to take one single tablet containing coformulated TAF/FTC (25/200mg) with or without food 2 to 24 hours before sexual intercourse followed by a second pill 24 hours after the first drug intake. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse and then a last pill 24 hours later.

Outcomes

Primary Outcome Measures

Efficacy of F/TAF
Number of HIV infections defined by the presence of HIV ribonucleic acid (RNA) in plasma through study completion (an average of two years) in the event-driven F/TAF arm.

Secondary Outcome Measures

Efficacy of F/TDF
Number of HIV infections defined by the presence of HIV ribonucleic acid (RNA) in plasma through study completion (an average of two years) in the event-driven F/TDF arm.
Acceptability of F/TAF versus F/TDF
Satisfaction score assessed by a self-administrated study medication satisfaction questionnaire.
Safety of F/TAF versus F/TDF
Numbers of participants experiencing, through study completion (an average of 2 years): at least one Grade 3 or 4 treatment-related adverse event as graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events [Corrected Version 2.1 July 2017], at least one serious adverse event as graded using the same tables. Change from baseline in estimated glomerular filtration rate at 1, 2, and 3 years. Change from baseline in body weight at 1, 2, and 3 years.

Full Information

First Posted
March 2, 2023
Last Updated
August 1, 2023
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Chiang Mai University, Thailand, Ministry of Health, Thailand, Assistance Publique - Hôpitaux de Paris, FRANCE, Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05813964
Brief Title
Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
Acronym
SimpPrEP
Official Title
A Randomized Controlled Trial to Evaluate the Efficacy, Acceptability and Safety of Event-driven Pre-exposure Prophylaxis for HIV Using TAF/FTC in Men Who Have Sex With Men in Thailand and France
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Chiang Mai University, Thailand, Ministry of Health, Thailand, Assistance Publique - Hôpitaux de Paris, FRANCE, Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy, acceptability, and safety of a simplified event-driven pre-exposure prophylaxis of HIV based on oral TAF/FTC in HIV-uninfected cisgender men who have sex with men (MSM). Primary objective: To assess the efficacy of emtricitabine 200 mg + tenofovir alafenamide 25 mg (F/TAF), taken 2 to 24 hours before sexual intercourse followed by a second dose 24 hours after the first intake, in reducing the risk of HIV acquisition in MSM relative to the background HIV incidence rate.
Detailed Description
The study will enroll HIV-uninfected MSM at risk for acquiring HIV infection. Participants will be enrolled over 2 years and followed up until the closure of the clinical study. Therefore, the follow up duration will be up to 3 years for first enrollees and up to1 year for the last enrollee. The study will be implemented in Thailand (60% of participants) and France (40%). Participants will be randomly assigned to one of two regimens: Experimental Arm (F/TAF): one tablet of the fixed-dose combination of emtricitabine (FTC) 200 mg + tenofovir alafenamide (TAF) 25mg, 2 to 24 hours before sexual intercourse followed by a second tablet 24 hours after the first intake. Control Arm (F/TDF): two tablets of the fixed-dose combination of emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg, 2 to 24 hours before sexual intercourse followed by a third tablet 24 hours after the first drug intake and a fourth tablet 24 hours later. Participants will attend up to 15 study visits throughout the study. Visits may include physical examinations, blood collection, urine collection, and swabs collection (oral and rectal). At the end of their study participation, all participants will be transitioned to locally available HIV prevention services, including PrEP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
PrEP exposure prophylaxis (PrEP), On-demand, Event-driven, TAF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a phase III, international, multicenter, open-label, parallel-group, randomized, controlled trial among cis men who have sex with men.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
524 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Event-driven PrEP with TDF/FTC
Arm Type
Active Comparator
Arm Description
Participants randomly assigned to the event-driven TDF/FTC arm will be instructed to take a loading dose of two single tablets containing coformulated TDF/FTC (300/200mg) 2 to 24 hours before sexual intercourse, followed by a third pill 24 hours after the first drug intake and a fourth pill 24 hours later. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse, then to take the two post-exposure pills.
Arm Title
Event-driven PrEP with TAF/FTC
Arm Type
Experimental
Arm Description
Participants randomly assigned to the event-driven TAF/FTC arm will be instructed to take one single tablet containing coformulated TAF/FTC (25/200mg) with or without food 2 to 24 hours before sexual intercourse followed by a second pill 24 hours after the first drug intake. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse and then a last pill 24 hours later.
Intervention Type
Drug
Intervention Name(s)
TDF/FTC 300mg/200mg fixed-dose combination tablets
Other Intervention Name(s)
Truvada
Intervention Description
Event-driven dosing regimen
Intervention Type
Drug
Intervention Name(s)
TAF/FTC 25mg/200mg fixed-dose combination tablets
Other Intervention Name(s)
Descovy
Intervention Description
Event-driven dosing regimen.
Primary Outcome Measure Information:
Title
Efficacy of F/TAF
Description
Number of HIV infections defined by the presence of HIV ribonucleic acid (RNA) in plasma through study completion (an average of two years) in the event-driven F/TAF arm.
Time Frame
All along the study
Secondary Outcome Measure Information:
Title
Efficacy of F/TDF
Description
Number of HIV infections defined by the presence of HIV ribonucleic acid (RNA) in plasma through study completion (an average of two years) in the event-driven F/TDF arm.
Time Frame
All along the study
Title
Acceptability of F/TAF versus F/TDF
Description
Satisfaction score assessed by a self-administrated study medication satisfaction questionnaire.
Time Frame
At 1 and at 2 years of follow up.
Title
Safety of F/TAF versus F/TDF
Description
Numbers of participants experiencing, through study completion (an average of 2 years): at least one Grade 3 or 4 treatment-related adverse event as graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events [Corrected Version 2.1 July 2017], at least one serious adverse event as graded using the same tables. Change from baseline in estimated glomerular filtration rate at 1, 2, and 3 years. Change from baseline in body weight at 1, 2, and 3 years.
Time Frame
All along the study

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Cisgender men
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male at birth age ≥ 18 years old Reporting having sex with men Negative 4th generation HIV-1 and HIV-2 test Reporting condomless anal sex with men not more often than two days during the previous month and able to plan their sexual activity Risk of HIV acquisition based on self-report of at least one of the following behaviors during the 6 months before enrollment: condomless anal sex with at least 2 different sexual partners, sexually transmitted infection (rectal chlamydia and/or rectal gonorrhea and/or syphilis), provided or received money goods or favor in exchange of sex, binge drinking or use of non-injectable recreational drugs. Consenting to participate and agreeing to follow the clinical trial procedures, including adherence to study visits every 3 months In France: Person affiliated with or benefiting from a social security system (article L1121-11of the public health code in France) Non-inclusion criteria: Women and trans women Taking feminizing hormone therapy Positive HIV test result at screening or enrollment even if HIV infection is not confirmed Positive hepatitis B surface antigen test ALT or AST > 4 ULN Estimated glomerular filtration rate < 60mL/min/1.73m² History of chronic kidney disease, osteoporosis, osteopenia or pathological fracture not related to trauma Hypersensitivity to the study products F/TDF or F/TAF Past or concurrent participation in a HIV vaccine trial or concurrent participation in another clinical trial without the agreement of the principal investigators of the two trials Use of intravenous drugs within the last 12 months Person under legal guardianship Not likely to comply with the clinical trial procedures or with any condition incompatible with study participation, upon the investigator's judgement. Ongoing Post-Exposure Prophylaxis (PEP) for HIV
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geoffroy LIEGEON, MD, PhD
Phone
+33 142494991
Email
geoffroy.liegeon@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gonzague JOURDAIN, MD, PhD
Phone
: +66 8 1883 0065
Email
gonzague.jourdain@phpt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffroy LIEGEON
Organizational Affiliation
Infectious Diseases Department, Saint-Louis Hospital, Paris, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sumet ONGWANDEE
Organizational Affiliation
Office of the Senior Expert Committee, Department of Disease Control, Ministry of Public Health, Nonthaburi, Thailand
Official's Role
Study Director
Facility Information:
Facility Name
AP-HP - Hôpital Saint-Louis
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Michel MOLINA, MD
Phone
+33 142494512
Email
jean-michel.molina@aphp.fr
First Name & Middle Initial & Last Name & Degree
Geoffroy LIEGEON, MD
Phone
+33 142494991
Email
geoffroy.liegeon@aphp.fr
Facility Name
STIs Clinic of the Office of Disease Prevention and Control Region 1
City
Chiang Mai
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thitipan AKKARASEREENON, MD
Phone
+66 25903817
Email
d_thitipan@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sumet ONGWANDEE, MD
Phone
+66 25903817
Email
sumet_o@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.

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