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OpenTrials
Completed

NCT Number: NCT02827227

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)

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).

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Key information

Conditions

HIV-infected Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon / Hôpital de la Croix Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PRIMIMMUNO

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2016
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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