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)

PHASE3CompletedINTERVENTIONAL
Enrollment

556

Participants

Timeline

Start Date

January 19, 2021

Primary Completion Date

February 19, 2023

Study Completion Date

April 19, 2024

Conditions
Unsafe SexRisk-Taking
Interventions
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.

Trial Locations (9)

75000

Hôpital Bichat, Paris

75181

Hôpital Hôtel Dieu, Paris

75475

Hôpital Saint-Louis, Paris

75571

Hôpital Saint-Antoine, Paris

75651

Hôpital pitié Salpetrière, Paris

Hôpital Pitié-Salpétrière, Paris

75743

Hôpital Necker-Enfants Malades, Paris

75908

Hôpital Européen Georges Pompidou, Paris

75970

Hôpital Tenon, Paris

All Listed Sponsors
lead

ANRS, Emerging Infectious Diseases

OTHER_GOV

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) | Biotech Hunter | Biotech Hunter