Informations générales (source: ClinicalTrials.gov)
Prevention of HIV in "Île-de-France" (ANRS-PREVENIR)
Interventional
N/A
ANRS, Emerging Infectious Diseases (Voir sur ClinicalTrials)
mai 2017
octobre 2024
05 octobre 2024
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.
Etablissements
Critères
Tous
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)
- 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)
- 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)