HIV Infection Clinical Trial
Official title:
EVALUATION DU RISQUE RESIDUEL DE TRANSMISSION DU VIH CHEZ DES HSH TRAITES AYANT UNE CHARGE VIRALE PLASMATIQUE INDETECTABLE
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.
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
;
Intervention Model: Single Group Assignment, Masking: Open Label
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