Penetration and Compartimentation of HIV

HIV Clinical Trial

Official title:

Penetration and Compartimentation of HIV in Genital Mucosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513758
• Other study ID #: 0201078
• Secondary ID: DGS 2002/0521
• Status: Completed
• Phase: N/A
• First received: July 30, 2015
• Last updated: March 22, 2016
• Start date: November 2002
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (> 18 year-old) HIV positive,

• HIV-CV> 1000 cp/ml,

Exclusion Criteria:

• children

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
France	LUCHT	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral tropism of HIV	number of HIV virus in sperm or cervical secretions.	Inclusion	No
Secondary	Genetic polymorphism for HIV strains	With a sequencing method, it is possible to classify the different strains in groups, according to their polymorphism.	Inclusion	No