NCT04597424

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 556 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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".

Conditions

• Unsafe Sex
• Risk-Taking

Interventions

Type	Name	Description
DRUG	Experimental: doxycycline	2 tablets of doxycycline 100 mg (monohydrate form) will be taken orally after each risk sexual intercourse, ideally within 24 hours after sex and no more than 72 hours. PEP should not be taken more than 3 times over a 7 days' period. If a participant has risk sexual intercourse for several consecutive days, PEP should be taken at least 48 hours apart and no more than 3 times 2 tablets over 7 days. A maximum of 3 intakes of 2 tablets will be allowed over a period of 7 days.
BIOLOGICAL	Bexsero® vaccine	1st injection of Bexsero® vaccine at inclusion visit, 2nd injection at week 8.

Timeline

• Start date: 2021-01-19
• Primary completion: 2023-02-19
• Completion: 2024-04-19
• First posted: 2020-10-22
• Last updated: 2026-04-06

Locations

9 sites across 1 country: France