Values of the Immune Activation Markers CD38 and HLA-DR and the Ratio CD4/CD8 According to the Delay of Combined AntiRetroviral Therapy (c-ART) Initiation in Primary HIV-infected Patients (PRIMIMMUNO)

NCT02827227 | Completed

• 1 other identifier: D21969
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The objective was to identify factors associated with the normalization of the CD4/CD8 ratio (\>=1) in patients with a history of primary HIV infection (PHI) and long-term combined antiretroviral therapy (cART).

Conditions

HIV-infected Patients

Keywords

HIV-infected patients; cART; immune restoration; markers

Outcome Measures

Primary Outcomes (1)

• percentage of CD4+ and CD8+ T lymphocytes with activation markers (CD38 + and HLA-DR)

  percentage of CD4+ and CD8+ T lymphocytes with activation markers (CD38 + and HLA-DR) according to the delay of cART initiation (early 3 months or delayed \> 3 months).

  Day 0

Study Arms (1)

Primary HIV- Infected patients

Primary HIV- Infected patients with a minimum of 2 years of effective cART.

Biological: lymphocytes immunophenotyping

Interventions

lymphocytes immunophenotyping BIOLOGICAL

The lymphocytes immunophenotyping were performed from fresh EDTA-anticoagulated blood harvested during a routine follow-up of patients in HIV Lyon centers. HIV patients with a known history of PHI and a minimum of 2 years of effective cART (\< 200 copies/mL) without interruption or virological failure were included in 2 centers in Lyon (Croix-Rousse and Edouard Herriot hospital). Baseline factors at the time of PHI, delay, type and duration of first and duration of total cART, CMV status, nadir CD4 cells count and level of activation markers on CD4 and CD8 cells (CD38 and HLA-DR) at the time of the study were assessed. Patients with hepatitis C or B virus co-infection or with a history of neoplasia or immunosuppressive therapy after the date of PIH were excluded.

Primary HIV- Infected patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV patients

You may qualify if:

• all HIV patients with a known history of PHI and a minimum of 2 years of effective cART (\< 200 copies/mL) without interruption or virological failure

You may not qualify if:

• Patients with hepatitis C or B virus co-infection or with a history of neoplasia or immunosuppressive therapy after the date of PIH

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon / Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Study Design

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

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: July 11, 2016
• Study Start: January 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

FR (1)