Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100
Phase 4
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00385957
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief Summary
The study analyzes the virological response in plasma and non-plasma compartments, as well as the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 \< 100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- Diagnosed HIV-1 infection.
- Age 18 years or over.
- No previous antiretroviral therapy.
- CD4 lymphocyte count of < 100 cells/mL.
- Patients who, sufficiently informed, give their written consent to participate in the study and undergo the tests and explorations involved in the study.
Exclusion Criteria
- Pregnant women, women who are breast feeding, or women who intend to become pregnant during the study period.
- Currently undergoing treatment for an opportunistic infection (parenteral administration).
- Any formal contraindication to treatment with the study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months. Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months.
- Secondary Outcome Measures
Name Time Method Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+) and levels of CD8 cells (CD28+ y CD38+) Incidence of adverse events
Trial Locations
- Locations (6)
Donostia Ospitaleak
🇪🇸San Sebastian, Giputzkoa, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
CSU Bellvitge
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinic
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain