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: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Treatments: Doxycycline

Criteria

Inclusion Criteria:

• Mens who have sex with mens (MSM) enrolled in the ANRS PREVENIR study.

• At least 6-month experience with PrEP (within the ANRS PREVENIR study or before starting the ANRS PREVENIR study).

• No clinical manifestation of primary HIV infection and no symptom of bacterial STI (chlamydia, gonorrhea, M. genitalium or syphilis).

• History of documented bacterial STI with at least one episode in the last 12 months.

• Participants who agree to sign the information and consent form specific to this study.

• Valid health insurance (State medical aid (AME) is not health insurance).

Exclusion Criteria:

• Syphilis diagnosed prior to inclusion without serologic evidence of cure (cure is defined as decreased by at least 4-fold of the non-treponemal antibody titer [Venereal Disease Research Laboratory (VDRL), Rapid Plasma Reagin (RPR)] relative to the titer at initiation of treatment of syphilis).

• HIV infection.

• Previous vaccination with Bexsero® or any other meningococcal B vaccine.

• Vaccination during the 4 weeks (28 days) preceding the first vaccination of the study.

• Previous vaccination with an experimental vaccine in the previous 5 years.

• Systemic treatment with retinoids : isotretinoin (Acnetrait®, Procuta®, Curacné®, Contracné®, …).

• Treatment with enzyme-inducing anticonvulsants (carbamazepine, phenobarbital, phenytoin, ….).

• Participant who has received immunoglobulins, a transfusion of blood or blood derivatives in the last 3 months.

• Known or suspected congenital or acquired immunodeficiency; immunosuppressive treatment in the last 6 months, such as cancer chemotherapy or radiotherapy; long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks in the last 3 months)

• Known allergy to antibiotics of the tetracycline family.

• Known allergy to any component of the Bexsero® vaccine.

• Known allergy to any component of the doxycycline pill.

• Known allergy to latex (contained in the vaccine cap).

• Thrombocytopenia or any other known coagulation disorder, which would be a contraindication to an intramuscular injection of Bexsero® vaccine.

• Documented oesophageal lesion

• Acute respiratory infection or severe acute febrile illness or systemic reaction that may present a significant risk if vaccinated in the month prior to inclusion.

• Any condition (clinical) that, in the investigator's opinion, would contraindicate intramuscular vaccination and blood sampling.

• Oral Anticoagulant treatment.

• Continuous treatment with doxycycline at inclusion.

• Vitamin A treatment in case of intake of 10 000 international unit or more.

• Participation in another research including an exclusion period still in progress at the time of inclusion.

• Under guardianship or curator, or deprived of liberty by a judicial or administrative decision.