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

Human Immunodeficiency Virus; HIV Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541085
• Other study ID #: CR017920
• Secondary ID: TMC114HIV0010
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2011
• Last updated: November 25, 2013
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2013
• Source: Janssen-Cilag S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus; HIV
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Darunavir/Ritonavir (DRV/r)
Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina regimen
• Efavirenz (EFV)
Efavirenz (EFV) + Tenofovir/Emtricitabina regimen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag S.p.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells		Baseline and Week 24	No
Secondary	Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells		Baseline, Week 12, and Week 48	No
Secondary	Change in peripheral T-lymphocyte immune phenotype		Baseline, Week 12, Week 24 and Week 48	No
Secondary	Change in peripheral T-lymphocyte turnover		Baseline, Week 12, Week 24 and Week 48	No