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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Human Immunodeficiency Virus; HIV

Intervention / Treatment
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* Drug: Darunavir/Ritonavir (DRV/r)
* Drug: Efavirenz (EFV)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Darunavir/Ritonavir (DRV/r)<br> | Drug: Darunavir/Ritonavir (DRV/r)<br>* Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina regimen<br>|
| Efavirenz (EFV)<br> | Drug: Efavirenz (EFV)<br>* Efavirenz (EFV) + Tenofovir/Emtricitabina regimen<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Immunodeficiency Virus; HIV; Highly Active Antiretroviral Therapy; HAART; Darunavir; Ritonavir; Efavirenz; Kinetics; Immunological Recovery