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COMPLETED
NCT01413152
NA

Residual Risk Assessment Of HIV Transmission

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

View on ClinicalTrials.gov

Summary

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.

Official title: EVALUATION DU RISQUE RESIDUEL DE TRANSMISSION DU VIH CHEZ DES HSH TRAITES AYANT UNE CHARGE VIRALE PLASMATIQUE INDETECTABLE

Key Details

Gender

MALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

167

Start Date

2011-07

Completion Date

2012-03

Last Updated

2026-04-23

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

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

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

Locations (1)

Jade Ghosn

Le Kremlin-Bicêtre, France