ClinicalTrials.gg
CompletedNCT03290755HEPCSEXUpdated Nov 14, 2018

Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux

An observational study in Human Immunodeficiency Virus (HIV) and Hepatitis c, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-14.

Primary conditionHepatitis CRegistry: Acquired Immunodeficiency SyndromeReclassifiedWhy we changed it
Registry
Acquired Immunodeficiency Syndrome — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hepatitis C
Why
  1. The registry often attaches Acquired Immunodeficiency Syndrome to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Hepatitis C.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University Hospital, Bordeaux · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
29
Ages
18 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 174 studies in Hepatitis C with a site in France — 10 open to participants now, 12 under way, 1 of them phase 3. Hepatitis C · France.

Enrollment
41st of 45
29 · median 300
Started
2017
with 13 others
Observational
45 of 174
7 open now
Registered
145th of 174
by date

Among the 174 studies in Hepatitis C with a site in France, this one is the 41st largest by enrollment of the 45 observational ones that give a count, is one of 14 that started in 2017, is one of 45 observational ones, and was the 145th registered.

Hepatitis C

1,744 studies on the registry are indexed under Hepatitis C; 98 are open to participants now.

Browse Hepatitis C studies →

Open to participants now

10 of the 174 studies in Hepatitis C with a site in France are open now. Recruiting first, the newest first:

5 more — sign in →

All 10 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 56 Hepatitis C studies recruiting now, 43 (77%) set no upper age limit and 6 (11%) stop at 75 or younger; 10 take children under 18; 26 take healthy volunteers.

This study: 18 Years and older · male · no healthy volunteers.

The full table on the hub →

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02

Study summary

The main objective of this study is to analyse sexual behavior of HIV + MSM in Bordeaux, who have sexually contracted hepatitis C between January 1st 2013, to January 31, 2017. These data will bring some improvement about prevention and maybe reduced the hepatitis C incidence.

Read the detailed description

Hepatitis C (HCV) is considered in part as a sexually transmitted infection (STI). A marked decrease in its incidence has been observed for several years, coinciding with the availability of new direct acting antiviral treatments (DAA). However, people are increasingly infected with the hepatitis C virus, especially HIV-positive MSM. This increase is explained by new sexual practices that are particularly at high level of risk, despite the widening accessibility of new DAA. Prevention also plays an important role in implementing an effective risk reduction policy. New methods of prevention must therefore be developed. For this purpose, it is imperative to know the natural history of acute hepatitis C, the different behaviours at risk of HCV transmission, and the demonstration of socio-sexual networks (clusters) thanks to virological phylogenetic studies. In order to improve hepatitis C prevention, we wish to establish a descriptive study focusing on :

  • Descriptive analysis of the natural history of hepatitis C,
  • Identification of patient clusters (phylogenetic analysis)
  • Description of the sexual behaviors of infected patients, through a semi-directed interview.
03

Conditions studied

  • Human Immunodeficiency Virus (HIV)
  • Hepatitis c

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Keywords

  • Hepatitis C
  • sexual network
  • sexual transmitted
  • men who have sex with men
  • HIV positive
  • sexual behaviour
04

In context

Hepatitis C Reclassified

1,744 studies on the registry are indexed under Hepatitis C; 98 are open to participants now.

This study's enrollment of 29 is below the median of 218 across 435 observational studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 807 studies on the registry; 198 are open to participants now.

Compared within Hepatitis C, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Men who have sex with Men co-infected HIV-HCV

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient older than 18 years
  • -1 and/or HIV-2 confirmed Infection
  • Men who have sex with Men
  • Patients included in the "ANRS CO3Aquitaine cohort".
  • contamination documented over the period 01/01/2013 to 01/31/2017 (A positive HCV serology and a HCV plasma RNA positive) AND a negative HCV serology OR a positive HCV serology and a negative plasma RNA before inclusion period
  • A person who has received information about the protocol and has given oral consent and that his / her non-opposition is documented in his / her medical file.

Exclusion criteria

Exclusion Criteria:

  • Transfusion contamination
  • Substance abuse IV out of SLAM context
  • Refusal to consent to research.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

06

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
29 participants (actual)
Patient registry
No

Groups and cohorts

  • MSM co-infected HIV-HCV

    Behavioral: semi-directed interviews

Interventions

  • Behavioralsemi-directed interviews

    semi-directed interviews in order to collect socio-behavioral data

07

What researchers measure

Primary outcomes

  1. Analyse sexual behaviours among HIV positive MSM in Bordeaux, through semi-directed interviews

    Time frame: At inclusion (day 0)

Secondary outcomes

  1. Identifying socio-sexual networks through phylogenetic analysis

    Time frame: At inclusion (day 0)

  2. Describing the natural history of sexual hepatitis C in HIV positive MSM

    Time frame: At inclusion (day 0)

08

Study locations

1 site
  • Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin
    Bordeaux, France
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Mar 2018, 4 months.

Of 102 non-industry observational studies under Hepatitis C, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 63. This study's 4 months is below that.

Counting every sponsor, half of 138 studies reached it within 33 months; a quarter within 18 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2017
First posted
Sep 25, 2017
StartActual
Nov 8, 2017
Primary completionActual
Mar 13, 2018
CompletionActual
Mar 13, 2018
Last update
Nov 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03290755
Responsible party
Sponsor
First posted
Sep 25, 2017
Start date
Nov 8, 2017
Primary completion
Mar 13, 2018
Completion
Mar 13, 2018
Last update
Nov 14, 2018

Study contacts

Linda WITTKOP, MD, PhD
study chair · Université de Bordeaux - ISPED - Inserm 2129 - CHU de Bordeaux
Charles CAZANAVE, Prof
principal investigator · University Hospital Bordeaux, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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