Residual Risk Assessment Of HIV Transmission

NCT01413152 | Completed

• 1 other identifier: AOO 370-41
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

men having sex with men

Outcome Measures

Primary Outcomes (1)

• 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

  up to 30 days

Secondary Outcomes (1)

• to characterize the biological and behavioral components that might influence VL discordance between blood and semen

  up to 30 days

Study Arms (1)

0

EXPERIMENTAL

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

Interventions

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

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

0

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under protection(saving) of justice

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Jade Ghosn

Le Kremlin-Bicêtre, France

Location

Related Publications (1)

• Ghosn J, Leruez-Ville M, Blanche J, Delobelle A, Beaudoux C, Mascard L, Lecuyer H, Canestri A, Landman R, Zucman D, Ponscarme D, Rami A, Viard JP, Spire B, Rouzioux C, Costagliola D, Suzan-Monti M; Evarist-ANRS EP 49 Study Group. HIV-1 DNA levels in peripheral blood mononuclear cells and cannabis use are associated with intermittent HIV shedding in semen of men who have sex with men on successful antiretroviral regimens. Clin Infect Dis. 2014 Jun;58(12):1763-70. doi: 10.1093/cid/ciu187. Epub 2014 Mar 18.

  PMID: 24647014 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections

Interventions

Blood Specimen Collection; Biological Specimen Banks

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Roland LANDMAN

  Service de maladies infectieuses, VIH et Maladies Tropicales-Hopital BUCHAT

  STUDY DIRECTOR

• Jade GHOSN

  Service de médecine interne Le Kremlin Bicetre

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: August 10, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 23, 2026

Record last verified: 2012-12

Locations

FR (1)