Health TrialsbyHealthPanel

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

ConditionHIV/AIDS
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorANRS, Emerging Infectious Diseases

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • TDF/FTC 300mg/200mg fixed-dose combination tablets

    Drug

    Event-driven dosing regimen

  • TAF/FTC 25mg/200mg fixed-dose combination tablets

    Drug

    Event-driven dosing regimen.

Treatment groups

524 Participants
are divided into 2 treatment groups
Group A: Event-driven PrEP with TDF/FTCActive comparator 1 intervention
Group B: Event-driven PrEP with TAF/FTCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
All along the study

Secondary outcomes

1

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.

Time frame
All along the study
2

Acceptability of F/TAF versus F/TDF

Satisfaction score assessed by a self-administrated study medication satisfaction questionnaire.

Time frame
At 1 and at 2 years of follow up.
3

Safety of F/TAF versus F/TDF

1. 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. 2. Change from baseline in estimated glomerular filtration rate at 1, 2, and 3 years. 3. Change from baseline in body weight at 1, 2, and 3 years.

Time frame
All along the study

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ANRS, Emerging Infectious Diseases

Lead sponsor

Chiang Mai University, Thailand

Collaborator

Ministry of Health, Thailand

Collaborator

Assistance Publique - Hôpitaux de Paris

Collaborator

Gilead Sciences

Collaborator

Source ClinicalTrials.gov
Apply now