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) (PRIMIMMUNO)

July 11, 2016 updated by: Hospices Civils de Lyon
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Hospices Civils de Lyon / Hôpital de la Croix Rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HIV patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary HIV- Infected patients
Primary HIV- Infected patients with a minimum of 2 years of effective cART.
Biological: lymphocytes immunophenotyping

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of CD4+ and CD8+ T lymphocytes with activation markers (CD38 + and HLA-DR)
Time Frame: Day 0
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 4, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D21969

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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