Residual Risk Assessment Of HIV Transmission (EP 49 EVARIST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT01413152
First received: July 1, 2011
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
HIV Infection
Biological: blood and semen sampling, specific biological exams and biobank and self administered questionnaires

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: EVALUATION DU RISQUE RESIDUEL DE TRANSMISSION DU VIH CHEZ DES HSH TRAITES AYANT UNE CHARGE VIRALE PLASMATIQUE INDETECTABLE

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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 [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to characterize the biological and behavioral components that might influence VL discordance between blood and semen [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]

Enrollment: 167
Study Start Date: July 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0 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

Detailed Description:

The secondary objective is to characterize the biological and behavioral components that might influence VL discordance between blood and semen.

Background: In most cases the semen VL reflects the blood VL. However some seropositive people with an undetectable blood VL have a detectable semen VL and thus might be at risk of HIV transmission in case of unprotected sexual behaviors. Most of the previously published studies were made on rather small numbers of HIV+ heterosexual men, were cross-sectional and did not address factors that might be associated with discordant VL between blood and semen. Few studies have been performed among seropositive MSM who are one of the most at-risk populations for HIV.

Issue: The working hypothesis is that virus present into reservoirs and risky sexual behaviors might influence discordance in VL between blood and semen in MSM. Our hypothesis is that this rate might be higher among MSM than among the general population due to the existence of biological and specific factors that could lead to HIV local replication. The main reasons to address this question in MSM are i) no or very few data available in this population; ii) the possibility to measure in this population the impact of life style determinants on semen VL (high number of sexual partners; risky sexual behaviors, multi-drugs consumption…); and iii) a strong expectation from this community to have new prevention strategies and clear information about the HIV transmission risk.

Outcomes: Quantitative data analysis will allow us to evaluate the proportion of people having a detectable semen VL, its variation according to time. Socio-behavioral data analysis will allow us to describe the sexual behaviors that might influence discordance of the VL between blood and semen in HIV+ MSM. These results will provide information on the HIV residual risk of transmission in treated MSM and to better target people who might be at risk for HIV transmission in case of unprotected sexual behaviors. Describing the socio-behavioral characteristics of these people will help to define adaptated interventions in order to improve HIV prevention in MSM

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413152

Locations
France
Jade Ghosn
Kremlin Bicetre, France
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Study Director: Roland LANDMAN Service de maladies infectieuses, VIH et Maladies Tropicales-Hopital BUCHAT
Study Director: Jade GHOSN Service de médecine interne Le Kremlin Bicetre
Principal Investigator: David ZUCMAN Service de médecine interne Hôpital Foch Suresnes
Principal Investigator: Diane PONSCARME Service de maladies infectieuses et tropicales Hôpital St Louis
Principal Investigator: Agathe RAMI Service de médecine interne Lariboisière
Principal Investigator: Jean-Paul VIARD Centre de diagnostic et thérapeutique Hôtel Dieu
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier: NCT01413152     History of Changes
Other Study ID Numbers: AOO 370-41
Study First Received: July 1, 2011
Last Updated: December 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
men having sex with men

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 18, 2014