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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
  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 Phase
Human Immunodeficiency Virus; HIV
Drug: Darunavir/Ritonavir (DRV/r)
Drug: Efavirenz (EFV)
Phase 4

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)

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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)
Groups/Cohorts 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

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Italy: Ethics Committee

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
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Darunavir
Efavirenz
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014