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

Janssen (J&J Innovative Medicine)

Status

Completed

Conditions

Human Immunodeficiency Virus; HIV

Treatments

Drug: Darunavir/Ritonavir (DRV/r)

Drug: Efavirenz (EFV)

Study type

Observational

Funder types

Industry

Identifiers

NCT01541085

CR017920

TMC114HIV0010 (Other Identifier)

Details and patient eligibility

About

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 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.

Enrollment

33 patients

Sex

All

Ages

30 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.