NCT02513758

Brief Summary

Genital mucosa is the main way of HIV penetration. Many cells can be involved (epithelial cells, Langerhans cells) and antibodies may also play a critical role. The investigators' study aims to precise the role of each type of cells, the interaction cell-cell and cell-antibodies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2002

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

12.1 years

First QC Date

July 30, 2015

Last Update Submit

March 22, 2016

Conditions

HIV

Keywords

HIV patientsGenital HIV penetration

Outcome Measures

Primary Outcomes (1)

  • Viral tropism of HIV

    number of HIV virus in sperm or cervical secretions.

    Inclusion

Secondary Outcomes (1)

  • Genetic polymorphism for HIV strains

    Inclusion

Study Arms (1)

HIV patients

Men will have blood sampling tubes of 10 ml each, a saliva sample and a sample of sperm Women will have a two blood sampling tubes of 10 ml each, a saliva sample and a sampling cervicovaginal secretions

Other: sample

Interventions

sampleOTHER

Men will have blood sampling tubes of 10 ml each, a saliva sample and a sample of sperm Women will have a two blood sampling tubes of 10 ml each, a saliva sample and a sampling cervicovaginal secretions

HIV patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV patients

You may qualify if:

  • Adults (\> 18 year-old) HIV positive,
  • HIV-CV\> 1000 cp/ml,

You may not qualify if:

  • children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LUCHT

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, saliva, sperm and cervicovaginal secretions

Study Officials

  • Frédéric LUCHT, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 3, 2015

Study Start

November 1, 2002

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 23, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)