Prevention of HIV in "Île-de-France"

• Status: Unknown status
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Interventional HIV prevention strategy based on pre-exposure prophylaxis (PrEP) with Truvada® for people in the Île-de-France area (or Paris region) who don't have HIV but who are at high risk of becoming infected with HIV (men who have sex with men (MSM), transgender men and women, heterosexual men and women, sex workers, migrants) in combination with overall prevention services (communautary-based or educational counselling; addiction, social and psychological care; condoms and lubricating gel; clean injection equipment; sexually transmitted diseases (STD) screening and treatment; hepatitis A virus (HAV), hepatitis B virus (HBV) and hepatitis C virus (HCV) vaccinations and post-exposure treatment of HIV infection as soon as possible after diagnosis using an antiretroviral combination recommended by the French Guidelines on HIV treatment).

The individual benefit being already demonstrated in clinical trials, the aim is to demonstrate the public health impact of the interventional HIV prevention strategy by reducing the risk of getting HIV-1 infection of at least 15% of new diagnosis of HIV infections among MSM/transgender in the Ile-de-France area after a 3-year period.

• Phase: N/A
• 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: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Men/transgender men/women who have sex with men, heterosexual men and women, sex workers

• Negative for HIV-1 and HIV-2 (with a fourth generation enzyme-linked immunosorbent assay (ELISA) assay)

• Willing the geocoding of the postal address and to be contacted via telephone or email, on a regular basis

• Willing to comply to visits schedule (every 3 months)

• Health security program

• Informed consent form signed

• High risk of acquiring HIV infection:

• For MSM and transgenders:

• Anal sex with at least two different sexual partners and no consistent condom use over the last 6 months

• And/or history of STD during the last 12 months (syphilis, gonorrhea , chlamydiae, HBV or HCV infection)

• And/or history of non-occupational post-exposure prophylaxis (PEP) during the last 12 months

• And/or using psycho-actives drugs during sexual intercourses (cocaine, gammahydroxybutyric acid (GHB), Methylenedioxymethamphetamine (MDMA), mephedrone)

• And/or having an HIV-infected sexual partner with a detectable plasma viral load (> 50 copies (cp)/milliliter (ml))

• For heterosexual:

• Sexual intercourse with 1 partner originating from regions with high prevalence of HIV infection (> 1%) (South America, Sub-Saharan Africa, South-East Asia, Eastern Europe, French Guyana) and no consistent condom use

• and/or sex workers

• and/or having a sexual partner who is an intravenous drug users sharing injection material

• and/or having an HIV-infected sexual partner with a detectable plasma viral load (> 50 cp/ml)

Exclusion Criteria:

• Stable and exclusive relationship with an HIV-negative partner, or with an HIV-positive partner on antiretroviral therapy (ART) with a plasma viral load < 50 cp/ml

• Positive HIV infection

• Clinical signs of positive HIV infection

• Consistent condom use during sexual intercourse

• Expected trip abroad for 3 consecutive months

• Creatinine clearance lower than 50ml/min

• History of chronic renal disease, osteoporosis or osteopenia

• Receiving an investigational drug

• Receiving or will receive potentially nephrotoxic treatments

• Gastro-intestinal condition that could limit drug absorption

• Potentially non compliant participants

• Breastfeeding

• Hypersensitivity to TDF/FTC

• Positive HBs antigen or isolated anti hepatitis B core (HBc) antibodies if not willing to take daily PrEP

• Severe condition (lymphoma, other cancers, cardio-vascular disease, end-stage renal failure, uncontrolled diabetes)