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

NCT ID: NCT01541085

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-06-30

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.

Conditions

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Human Immunodeficiency Virus; HIV

Keywords

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Human Immunodeficiency Virus; HIV; Highly Active Antiretroviral Therapy; HAART; Darunavir; Ritonavir; Efavirenz; Kinetics; Immunological Recovery

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Darunavir/Ritonavir (DRV/r)

Darunavir/Ritonavir (DRV/r)

Intervention Type DRUG

Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina regimen

Efavirenz (EFV)

Efavirenz (EFV)

Intervention Type DRUG

Efavirenz (EFV) + Tenofovir/Emtricitabina regimen

Interventions

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Darunavir/Ritonavir (DRV/r)

Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina regimen

Intervention Type DRUG

Efavirenz (EFV)

Efavirenz (EFV) + Tenofovir/Emtricitabina regimen

Intervention Type DRUG

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag S.p.A., Italy Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag S.p.A.

Other Identifiers

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TMC114HIV0010

Identifier Type: OTHER

Identifier Source: secondary_id

CR017920

Identifier Type: -

Identifier Source: org_study_id