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Residual Risk Assessment Of HIV Transmission

NCT01413152 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • HIV Infection

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

Sponsors & Collaborators

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Roland LANDMAN · Service de maladies infectieuses, VIH et Maladies Tropicales-Hopital BUCHAT

  • Jade GHOSN · Service de médecine interne Le Kremlin Bicetre

  • David ZUCMAN · Service de médecine interne Hôpital Foch Suresnes

  • Diane PONSCARME · Service de maladies infectieuses et tropicales Hôpital St Louis

  • Agathe RAMI · Service de médecine interne Lariboisière

  • Jean-Paul VIARD · Centre de diagnostic et thérapeutique Hôtel Dieu

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01413152 on ClinicalTrials.gov