NCT00894257

Brief Summary

According to the centres taking part in the ALHICE survey, the number of HIV-HCV co-infected women is currently decreasing. This drop was first noted in 2006 and persisted in 2007. What might have been considered a chance phenomenon during the first year (2006) was confirmed in the beginning of 2008. In view of this information, the investigators wished to ascertain the reality of this trend and to investigate its causes, by attempting to answer the following questions: - Has the prevalence of risk factors for HCV infection changed among the general population over the past 10 years?

  • Has the prevalence of risk factors for HCV infection changed among HIV/HCV co-infected women over the past 10 years?
  • Is the change in the number of co-infected women who gave birth during the past 10 years related to the prevalence of certain risk factors among this population?
  • Is the change in the number of co-infected women who gave birth during the past 10 years related to a decrease in certain risk factors for HCV infection among the general population?
  • Have changes in addictive behaviour among women of child-bearing age played a role in the decreasing number of HCV-contaminated children? Furthermore, follow-up data from HCV-infected children born during this period will provide information concerning the course of HCV infection. The objectives are to study trends in numbers of deliveries among HCV/HIV co-infected women as well as trends in risk factors for HCV infection among women of child bearing age and lastly to create a cohort of HCV infected children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
19 days until next milestone

Study Start

First participant enrolled

May 25, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2014

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

4.9 years

First QC Date

May 5, 2009

Last Update Submit

November 9, 2023

Conditions

Keywords

HCV infected pregnant women

Study Arms (1)

HCV/HIV infected pregnant women

Eligibility Criteria

Age15 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

HCV/HIV infected pregnant women

You may qualify if:

  • Infected HIV/HCV pregnant women
  • All women to give birth in 1 randomized week each 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Montpellier

Montpellier, 34000, France

Location

CHU Nice

Nice, 06000, France

Location

CHU Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Hepatitis CHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Eugénia MARINE-BARJOAN, MD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 6, 2009

Study Start

May 25, 2009

Primary Completion

April 15, 2014

Study Completion

April 15, 2014

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations