Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Penetration and Compartimentation of HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02513758
Recruitment Status : Completed
First Posted : August 3, 2015
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.

Condition or disease Intervention/treatment
HIV Other: sample

Detailed Description:
At inclusion, men will have a two blood sampling tubes of 10 ml each, a saliva sample and a sample of sperm and women will have a two blood sampling tubes of 10 ml each, a saliva sample and a sampling cervicovaginal secretions

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Penetration and Compartimentation of HIV in Genital Mucosa
Study Start Date : November 2002
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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
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




Primary Outcome Measures :
  1. Viral tropism of HIV [ Time Frame: Inclusion ]
    number of HIV virus in sperm or cervical secretions.


Secondary Outcome Measures :
  1. Genetic polymorphism for HIV strains [ Time Frame: Inclusion ]
    With a sequencing method, it is possible to classify the different strains in groups, according to their polymorphism.


Biospecimen Retention:   Samples Without DNA
blood, saliva, sperm and cervicovaginal secretions


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV patients
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • children

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513758


Locations
Layout table for location information
France
LUCHT
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Layout table for investigator information
Principal Investigator: Frédéric LUCHT, PhD CHU SAINT-ETIENNE

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02513758     History of Changes
Other Study ID Numbers: 0201078
DGS 2002/0521 ( Other Identifier: Health general direction )
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
HIV patients
Genital HIV penetration