Clinical trial NCT01541085: An Immunologic Study of Treatment-Naive HIV Patients Starting a Darunavir/Ritonavir- or Efavirenz-Based HAART
Official title: 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: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus; HIV
Keywords: Human Immunodeficiency Virus; HIV; Highly Active Antiretroviral Therapy; HAART; Darunavir; Ritonavir; Efavirenz; Kinetics; Immunological Recovery
Lead sponsor: Janssen-Cilag S.p.A.
Sponsor class: INDUSTRY
First posted: 2012-02-29
Enrollment: 33
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Antiretroviral treatment-naive patients with advanced HIV infection starting a Darunavir/Ritonavir - or Efavirenz-based HAART regimen. Patients with advanced HIV infection are defined by a treatment-naïve CD4+ cell count \>50 to \<250 cells/mm3.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells
timeFrame: Baseline, Week 12, and Week 48
measure: Change in peripheral T-lymphocyte immune phenotype
timeFrame: Baseline, Week 12, Week 24 and Week 48
measure: Change in peripheral T-lymphocyte turnover
timeFrame: Baseline, Week 12, Week 24 and Week 48
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag S.p.A.
name: Janssen-Cilag S.p.A., Italy Clinical Trial
role: STUDY_DIRECTOR
References: