Status:
COMPLETED
Pilot Opened Trial in HIV-infected Patients Including an Investigational Marketed Product
Lead Sponsor:
Germans Trias i Pujol Hospital
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
This study aims to provide new knowledge about the pathogenesis of HIV infection, specifically, the role that immune activation and apoptotic activity play in immune recovery, and in particular, in th...
Detailed Description
One of the many adverse consequences of the human immunodeficiency virus (HIV) infection is the increase in the rate of lymphocyte cell death (Badley AD, Blood. 2000; 96:2951-64). Increased lymphocyte...
Eligibility Criteria
Inclusion
- Patient having a diagnosis of HIV infection, on continuously HAART for at least 2 years, including:
- 2 NRTI/NtRTIs (except ddI+TDF), plus
- 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir/ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or 1 NNRTI (nevirapine or efavirenz)
- Undetectable plasma HIV-1 RNA (VL \< 50 copies/mL) during the last 2 years prior to screening (with at least 4 determinations of viral load during this time period).
- Good treatment adherence.
- No presence of other factors which could contribute to CD4+ declines, such as treatment with chemotherapy, treatment with interferon/ribavirin, a ddI+TDF-containing regimen, etc, at least 12 months prior to screening.
- Patient classified as "discordant" who showed high level of CD8+HLADR+CD38+ and cell death values at the screening (see reference values in the definition section in page 9: 4.2. AIMS).
- Voluntary written informed consent.
Exclusion
- Pregnancy or fertile women willing to be pregnant.
- Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
- Hepatic toxicity (AST, ALT levels grade +/= 3).
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00773708
Start Date
March 1 2009
End Date
May 1 2011
Last Update
March 11 2015
Active Locations (1)
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1
H.U. Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916