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)

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.

Timeline

Start

2021-01-19

Primary completion

2023-02-19

Completion

2024-04-19

Outcome

Mixed primary results

paper 8·8 per 100 person-years (35 events in 362 participants) in the doxycycline PEP group and 53·2 per 100 person-years PMID 38797183 ↗

paper adjusted hazard ratio [aHR] 0·17 [95% CI 0·12-0·26]; p<0·0001 PMID 38797183 ↗

paper 4CmenB vaccine group and 77·1 per 100 person-years (122 events in 270 participants) in the no vaccine group PMID 38797183 ↗

paper aHR 0·78 [95% CI 0·60-1·01]; p=0·061 PMID 38797183 ↗

Publications

• Molina JM, Bercot B, Assoumou L, Rubenstein E, Algarte-Genin M, Pialoux G, Katlama C, Surgers L, Bebear C, Dupin N, Ouattara M, Slama L, Pavie J, Duvivier C, Loze B, Goldwirt L, Gibowski S, Ollivier M, Ghosn J, Costagliola D; ANRS 174 DOXYVAC Study Group. Doxycycline prophylaxis and meningococcal group B vaccine to prevent bacterial sexually transmitted infections in France (ANRS 174 DOXYVAC): a multicentre, open-label, randomised trial with a 2 x 2 factorial design. Lancet Infect Dis. 2024 Oct;24(10):1093-1104. doi: 10.1016/S1473-3099(24)00236-6. Epub 2024 May 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bexsero	Vaccine	—	Intramuscular
Subject	Doxycycline	Small molecule	200 mg	Oral

Indications

No indication recorded.