An Immunologic Study of Treatment-Naive HIV Patients Starting a Darunavir/Ritonavir- or Efavirenz-Based HAART

Ex Vivo Study of Immune-Reconstitution Kinetics in HIV-infected ARV-naive Subjects, With Advanced Disease, Starting a Darunavir/Ritonavir or Efavirenz Based HAART (IMMUNO Study)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01541085

Enrollment

Registered

2012-02-29

Start date

2011-12-31

Completion date

2013-06-30

Last updated

2013-11-26

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

Conditions

Human Immunodeficiency Virus; HIV

Keywords

Human Immunodeficiency Virus; HIV; Highly Active Antiretroviral Therapy; HAART; Darunavir; Ritonavir; Efavirenz; Kinetics; Immunological Recovery

Brief summary

The purpose of this study is to study the kinetics (study of the rate of change) of immune recovery quality and function in stored plasma blood samples of treatment-naive (not previously treated with antiretroviral drugs) patients with advanced human immunodeficiency virus (HIV) infection starting a Darunavir/Ritonavir- or Efavirenz-based highly active antiretroviral therapy (HAART) regimen.

Detailed description

This is an ex-vivo study (study which takes place outside the organism and records immune parameters from stored blood and cells of a defined population without any intervention by the researcher) to evaluate the kinetics (study of the rate of change) of immune recovery quality and function in stored plasma blood samples of treatment-naive (not previously treated with antiretroviral drugs) patients with advanced human immunodeficiency virus (HIV) infection starting a Darunavir/Ritonavir (DRV/r)- or Efavirenz (EFV)-based highly active antiretroviral therapy (HAART) regimen. In previously stored plasma blood samples, the role of DRV/r compared with EFV in reducing T-lymphocyte activation, DRV/r compared with EFV in recovering T-lymphocyte immune phenotype in peripheral blood and thymic production, and DRV/r compared with EFV in recovering T-lymphocyte function (functional immunity) will be studied. Blood samples will be analyzed before (baseline) and up to 48 weeks after initiating HAART. Each patient will receive orally administered (given by mouth) regimens of either Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina or Efavirenz (EFV) + Tenofovir/Emtricitabina.

Interventions

DRUGDarunavir/Ritonavir (DRV/r)

Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina regimen

DRUGEfavirenz (EFV)

Efavirenz (EFV) + Tenofovir/Emtricitabina regimen

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Documented human immunodeficiency (HIV)-1 infection * At baseline plasma blood sampling, has never received antiretroviral therapy * Attending the Clinic of Infectious Diseases of the University of Milan at San Paolo Hospital * Asymptomatic (demonstrating no acquired immunodeficiency syndrome \[AIDS\]-defining symptoms) at Baseline, Week 12, and Week 24 * CD4 cell count \>50 to \<250/mm3 at Baseline * Receiving treatment with either Darunavir/Ritonavir + Tenofovir/Emtricitabina or Efavirenz + Tenofovir/Emtricitabina highly active antiretroviral therapy (HAART) regimens at Week 12, Week 24, and Week 48 plasma blood sampling.

Exclusion criteria

is not defined in protocol.

Design outcomes

Primary

Measure	Time frame
Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells	Baseline and Week 24

Secondary

Measure	Time frame
Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells	Baseline, Week 12, and Week 48
Change in peripheral T-lymphocyte immune phenotype	Baseline, Week 12, Week 24 and Week 48
Change in peripheral T-lymphocyte turnover	Baseline, Week 12, Week 24 and Week 48

Outcome results

None listed

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