An Immunologic Study of Treatment-Naive HIV Patients Starting a Darunavir/Ritonavir- or Efavirenz-Based HAART
Information provided by (Responsible Party)
First received: August 23, 2011
Last updated: November 25, 2013
Last Verified: November 2013
History of Changes
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.
Human Immunodeficiency Virus; HIV
Drug : Darunavir/Ritonavir (DRV/r)
Drug : Efavirenz (EFV)
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 ]
- 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 ]
|Study Start Date:||December 2011|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina regimen
Efavirenz (EFV) + Tenofovir/Emtricitabina 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.
|Ages Eligible for Study:||30 Years to 50 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Study PopulationAntiretroviral 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.
- 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
Exclusion Criteria is not defined in protocol.
Contacts and LocationsChoosing 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 CollaboratorsJanssen-Cilag S.p.A.
|Study Director:||Janssen-Cilag S.p.A., Italy Clinical Trial||Janssen-Cilag S.p.A.|
|Responsible Party:||Janssen-Cilag S.p.A.|
|ClinicalTrials.gov Identifier:||NCT01541085 History of Changes|
|Other Study ID Numbers:||CR017920|
|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
Immunologic Deficiency Syndromes
ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.