Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Janssen-Cilag S.p.A.


Information provided by (Responsible Party)
Janssen-Cilag S.p.A.
ClinicalTrials.gov Identifier
NCT01541085

First received: August 23, 2011
Last updated: November 25, 2013
Last Verified: November 2013
History of Changes
Purpose

Purpose

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.

Condition Intervention
Human Immunodeficiency Virus; HIV

Drug : Darunavir/Ritonavir (DRV/r)
Drug : Efavirenz (EFV)

Study Type: Observational
Study Design: Time Perspective: Retrospective
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)

Further study details as provided by Janssen-Cilag S.p.A.:

Primary Outcome Measures

  • Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells [ Time Frame: Baseline and Week 24 ]
Secondary Outcome Measures:
  • Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells [ Time Frame: Baseline, Week 12, and Week 48 ]
  • Change in peripheral T-lymphocyte immune phenotype [ Time Frame: Baseline, Week 12, Week 24 and Week 48 ]
  • Change in peripheral T-lymphocyte turnover [ Time Frame: Baseline, Week 12, Week 24 and Week 48 ]

Enrollment: 33
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Darunavir/Ritonavir (DRV/r)

Drug: Darunavir/Ritonavir (DRV/r)

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

Efavirenz (EFV)

Drug: Efavirenz (EFV)

Efavirenz (EFV) + Tenofovir/Emtricitabina regimen

Detailed 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.

Eligibility

Eligibility

Ages Eligible for Study: 30 Years to 50 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

Antiretroviral treatment-naive patients with advanced HIV infection starting a Darunavir/Ritonavir - or Efavirenz-based HAART regimen. Patients with advanced HIV infection are defined by a treatment-naïve CD4+ cell count >50 to <250 cells/mm3.

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541085

Sponsors and Collaborators

Janssen-Cilag S.p.A.

Investigators

Study Director: Janssen-Cilag S.p.A., Italy Clinical Trial Janssen-Cilag S.p.A.
More Information

More Information


Responsible Party: Janssen-Cilag S.p.A.  
ClinicalTrials.gov Identifier: NCT01541085   History of Changes  
Other Study ID Numbers: CR017920  
  TMC114HIV0010  
Study First Received: August 23, 2011  
Last Updated: November 25, 2013  

Keywords provided by Janssen-Cilag S.p.A.:

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Ritonavir
Darunavir
Efavirenz

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.