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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag S.p.A.
• Treatments: Darunavir; Efavirenz; Ritonavir

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.