Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP) - Doxyvac

INSERM ANRS0 个研究点目标入组 720 人开始时间: 2019年10月2日最近更新: 2024年3月12日

适应症

试验速览

暂无简介。

•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 (Aide Médicale d'Etat AME” is not health insurance)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 720
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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 [VDRL, RPR] relative to the titer at initiation of treatment of syphilis)
•HIV infection.
•Previous vaccination with Bexsero®
•Systemic treatment with retinoids (Acnetrait®, Procuta®, Curacné®, Contracné®, ….).
•Treatment with enzyme-inducing anticonvulsants (carbamazepine, phenobarbital, phenytoïne, ….)
•Known or documented failure of the immune system, which would impair the immune response to the vaccine, such as subjects with inherited deficiency of complement, or immunosuppressive therapy
•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 esophageal lesion
•Continuous treatment with doxycycline at D0DV/inclusion
•Vitamin A treatment in case of intake of 10 000IU/d or more
•Participation in another research including an exclusion period still in progress at the time of inclusion
•Under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision

发起方

INSERM ANRS