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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 2013

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

  • Drug: Darunavir/Ritonavir (DRV/r)
    • Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina regimen
  • Drug: Efavirenz (EFV)
    • Efavirenz (EFV) + Tenofovir/Emtricitabina regimen

Arms, Groups and Cohorts

  • Darunavir/Ritonavir (DRV/r)
  • Efavirenz (EFV)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Janssen-Cilag S.p.A.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Janssen-Cilag S.p.A., Italy Clinical Trial, Study Director, Janssen-Cilag S.p.A.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.