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

NCT01541085 | Completed

• 2 other identifiers: CR017920TMC114HIV0010
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Human Immunodeficiency Virus; HIV

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells

  Baseline and Week 24

Secondary Outcomes (3)

• Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells

  Baseline, Week 12, and Week 48

• Change in peripheral T-lymphocyte immune phenotype

  Baseline, Week 12, Week 24 and Week 48

• Change in peripheral T-lymphocyte turnover

  Baseline, Week 12, Week 24 and Week 48

Study Arms (2)

Darunavir/Ritonavir (DRV/r)

Drug: Darunavir/Ritonavir (DRV/r)

Efavirenz (EFV)

Drug: Efavirenz (EFV)

Interventions

Darunavir/Ritonavir (DRV/r) DRUG

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

Darunavir/Ritonavir (DRV/r)

Efavirenz (EFV) DRUG

Efavirenz (EFV) + Tenofovir/Emtricitabina regimen

Efavirenz (EFV)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Janssen-Cilag S.p.A.: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Darunavir; Ritonavir; efavirenz

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles

Study Officials

• Janssen-Cilag S.p.A., Italy Clinical Trial

  Janssen-Cilag S.p.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: February 29, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 26, 2013

Record last verified: 2013-11