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Residual Risk Assessment Of HIV Transmission
Residual Risk Assessment Of HIV Transmission

NCT01413152

CompletedNA

Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Conditions: HIV Infection

Interventions: blood and semen sampling, specific biological exams and biobank and self administered questionnaires

Countries: France

The main objective of this one year multidisciplinary research is to estimate the frequency of seropositive men having sex with men (MSM) under antiretroviral therapy (ART) having an undetectable blood viral load (VL) and a detectable VL in semen. Design: Participants'inclusion (n=150) will be done in 6 HIV hospital departments participating to the research project. To warrant feasibility and diversity of participants needed, the centers will be located in Paris and nearby suburbs. The study design is based on one blood and semen sample taken at day 0 and at day 30. Blood and semen samples will be taken in the enrolment centers. Biological and virological analyses will be performed by the laboratory of microbiology at Necker hospital, on blood and semen samples. Pharmacological analyses are planned in a subsequent study. Socio-behavioral data will be collected through a self-administered questionnaire at day 0 and day 30. Schedule: Patients' enrolment, collection of biological samples and questionnaires will last 10 months (end of first quarter 2012). Biological and virological analyses will be performed until the end of the first semester 2012. Quantitative and socio-behavioral data will be analyzed during the third quarter 2012. Results will be released at the beginning of year 2013.

Eligibility overview

Sex: MALE

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Age ≥ 18 and
* Able to give written consent
* Covered by French Social Security
* be a men and have sex with men
* be treated with the same ARV treatment for at least 3 months
* blood plasma have a CV undetectable (\<50 copies / ml) for at least 6 months
* accept the constraints imposed by the study, that is to say one or more masturbation in hospital

Exclusion Criteria:

* Under protection(saving) of justice
Locations (1)
  • Le Kremlin-Bicêtre, France