Human Immunodeficiency Virus; HIV Clinical Trial
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)
Verified date | November 2013 |
Source | Janssen-Cilag S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 50 Years |
Eligibility |
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. |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen-Cilag S.p.A. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells | Baseline and Week 24 | No | |
Secondary | Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells | Baseline, Week 12, and Week 48 | No | |
Secondary | Change in peripheral T-lymphocyte immune phenotype | Baseline, Week 12, Week 24 and Week 48 | No | |
Secondary | Change in peripheral T-lymphocyte turnover | Baseline, Week 12, Week 24 and Week 48 | No |