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Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP) — DOXYVAC  

Risk-Taking Clinical Trial

Official title:
Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP)

Clinical Trial Summary

The study ANRS 174 Doxyvac is a clinical trial that will use Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men and using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP) and vaccination with Bexsero.

Clinical Trial Description

This is a randomized study with a factorial design for the 2 biomedical interventions (interventions 1 and 2). Subjects will be randomized and assigned to two different interventions: - Intervention 1: PEP with doxycycline or no PEP. Subjects will be randomized 2/1 to receive doxycycline PEP or no PEP - Intervention 2: Meningococcal B vaccine (Bexsero®) or no vaccine Subjects will be randomized 1/1 to received 2 doses of Bexsero® vaccine (at the first visit and two months later) or no vaccine Participants will be randomized in one of the following arms: - Arm 1: doxycycline and Bexsero® vaccine (240 participants) - Arm 2: doxycycline and no Bexsero® vaccine (240 participants) - Arm 3: no doxycycline and Bexsero® vaccine (120 participants) - Arm 4: no doxycycline and no Bexsero® vaccine (120 participants) Randomization will be stratified by whether or not the participant enters in the ancillary study "intestinal microbiota". ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04597424
Study type Interventional
Source ANRS, Emerging Infectious Diseases
Contact
Status Active, not recruiting
Phase Phase 3
Start date January 19, 2021
Completion date September 2023
View Details
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