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

This study has been completed.
Sponsor:
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

August 23, 2011
November 25, 2013
December 2011
June 2013   (final data collection date for primary outcome measure)
Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01541085 on ClinicalTrials.gov Archive Site
  • Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells [ Time Frame: Baseline, Week 12, and Week 48 ] [ Designated as safety issue: No ]
  • Change in peripheral T-lymphocyte immune phenotype [ Time Frame: Baseline, Week 12, Week 24 and Week 48 ] [ Designated as safety issue: No ]
  • Change in peripheral T-lymphocyte turnover [ Time Frame: Baseline, Week 12, Week 24 and Week 48 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Immunologic Study of Treatment-Naive HIV Patients Starting a Darunavir/Ritonavir- or Efavirenz-Based HAART
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)

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.

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.

Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

Human Immunodeficiency Virus; HIV
  • Drug: Darunavir/Ritonavir (DRV/r)
    Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina regimen
  • Drug: Efavirenz (EFV)
    Efavirenz (EFV) + Tenofovir/Emtricitabina regimen
  • Darunavir/Ritonavir (DRV/r)
    Intervention: Drug: Darunavir/Ritonavir (DRV/r)
  • Efavirenz (EFV)
    Intervention: Drug: Efavirenz (EFV)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
June 2013
June 2013   (final data collection date for primary outcome measure)

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.

Both
30 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01541085
CR017920, TMC114HIV0010
No
Janssen-Cilag S.p.A.
Janssen-Cilag S.p.A.
Not Provided
Study Director: Janssen-Cilag S.p.A., Italy Clinical Trial Janssen-Cilag S.p.A.
Janssen-Cilag S.p.A.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP