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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)

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02827227
Acronym
PRIMIMMUNO
Enrollment
99
Registered
2016-07-11
Start date
2014-01-31
Completion date
2016-02-29
Last updated
2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-infected Patients

Keywords

HIV-infected patients, cART, immune restoration, markers

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).

Interventions

BIOLOGICALlymphocytes 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
percentage of CD4+ and CD8+ T lymphocytes with activation markers (CD38 + and HLA-DR)Day 0percentage 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026