An Immunologic Study of Treatment-Naive HIV Patients Starting a Darunavir/Ritonavir- or Efavirenz-Based HAART
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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) |
- Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated 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 |
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.
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
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: | May 9, 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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Ritonavir Darunavir |
Efavirenz HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013