HIV Infections
Conditions
Keywords
Treatment Naive
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).
Interventions
DRUGAZT+3TC+IDV+RTV
DRUGAZT+3TC+EFV
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Outcome results
None listed