HIV InfectionEP 49 EVARISTNCT01413152
Residual Risk Assessment Of HIV Transmission
A study testing blood and semen sampling, specific biological exams and biobank and self administered questionnaires in people with HIV Infection, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- HIV Infection
- What is being tested?
- blood and semen sampling, specific biological exams and biobank and self administered questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under protection(saving) of justice
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- HIV Infection
- Being tested
- blood and semen sampling, specific biological exams and biobank and self administered questionnaires
- Keywords
- men having sex with men
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and semen sampling, specific biological exams and biobank and self administered questionnairesBiological
blood and semen sampling, specific biological exams and biobank and self administered questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 0 | Experimental | Not described Receives: Biological: blood and semen sampling, specific biological exams and biobank and self administered questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 30 days
Secondary outcomes (1)
to characterize the biological and behavioral components that might influence VL discordance between blood and semen
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Roland LANDMAN, Study director, Service de maladies infectieuses, VIH et Maladies Tropicales-Hopital BUCHATJade GHOSN, Study director, Service de médecine interne Le Kremlin BicetreDavid ZUCMAN, Principal investigator, Service de médecine interne Hôpital Foch SuresnesDiane PONSCARME, Principal investigator, Service de maladies infectieuses et tropicales Hôpital St LouisAgathe RAMI, Principal investigator, Service de médecine interne LariboisièreJean-Paul VIARD, Principal investigator, Centre de diagnostic et thérapeutique Hôtel Dieu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413152
- Sponsor's protocol ID
- AOO 370-41
- Acronym
- EP 49 EVARIST
- Status last verified
- Dec 2012
- First submitted
- 1 Jul 2011
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24647014
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION DU RISQUE RESIDUEL DE TRANSMISSION DU VIH CHEZ DES HSH TRAITES AYANT UNE CHARGE VIRALE PLASMATIQUE INDETECTABLE
- ClinicalTrials.gov ID
- NCT01413152
- Acronym / sponsor ID
- EP 49 EVARIST / AOO 370-41
- Conditions
- HIV Infection
- Keywords
- men having sex with men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0 | Experimental | Biological: blood and semen sampling, specific biological exams and biobank and self administered questionnaires |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Under protection(saving) of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and semen sampling, specific biological exams and biobank and self administered questionnairesblood and semen sampling, specific biological exams and biobank and self administered questionnaires | Biological | 0 |
Primary outcome
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
1 secondary outcome
to characterize the biological and behavioral components that might influence VL discordance between blood and semen
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Results publication: PubMed 24647014Ghosn 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland LANDMAN study director
Service de maladies infectieuses, VIH et Maladies Tropicales-Hopital BUCHAT
Jade GHOSN study director
Service de médecine interne Le Kremlin Bicetre
David ZUCMAN principal investigator
Service de médecine interne Hôpital Foch Suresnes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood and semen sampling, specific biological exams and biobank and self administered questionnaires in people with HIV Infection, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01413152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.