Patients infected with human immunodeficiency virus who have never received antiretroviral treatment.
Conditions
Interventions
Trade Name: Reyataz
Product Name: ATAZANAVIR
Pharmaceutical Form: Tablet
INN or Proposed INN: Atazanavir sulfato
Other descriptive name: ATAZANAVIR SULFATE
Concentration unit: mg milligram(s)
Concentr
Sponsors
Fundación para la Investigación Biomédica del Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - HIV-positive by ELISA and confirmed by WB - Age> 18 years - Never have received antiretroviral treatment for HIV - CV baseline of HIV> 100,000 copies / mL - No evidence of genotypic resistance against antiretroviral - Study HLA B5701 negative - Having a VL =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women and women of childbearing age who are not committed to use adequate contraception method. 2. Previous history of serious confounding neurological comorbidities defined as: - Dependence on drugs or alcohol - CNS opportunistic infections - Major depression or psychosis - Previous diagnosis of dementia - Mental retardation - CNS neurological disease - Co-infection with hepatitis C virus 3. Claustrophobia 4. Existence of magnetizable body devices 5. Inability to perform and complete a full neurologic assessment 6. Renal insufficiency (creatinine clearance 10% calculated by Framingham 8. The following analytical criteria: - Neutropenia <750 cells / ?L - Hemoglobin <8.0 g / dL - Platelets <50,000 cells / ?L - Levels of GOT, GPT and GGT greater than 5 times the baseline levels
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Changes in the levels of N-acetyl-aspartate (NAA) in the basal brain ganglia;Secondary Objective: - Change in neurocognitive functioning - Changes in the levels of NAA in the frontal lobe - Changes in the levels of choline, myoinositol and glutamate in the basal ganglia and frontal lobe - Change in the volume of brain structures - Changes in the white matter abnormalities - Virologic failure - Therapeutic failure - Changes in the levels of CD4 - Adherence to HAART - Adverse effects;Primary end point(s): Variation of NAA levels in the cerebral basal ganglia, measured by NMR spectroscopy between two different HAART regimens with different penetration in the CNS;Timepoint(s) of evaluation of this end point: From baseline to week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-Variation of the "Global Defict Score" (GDS) 2-Variation of NAA levels in the structures of the frontal cortex as measured by NMR spectroscopy 3-Glutamate and choline levels in the basal ganglia structures and frontal cortex as measured by NMR spectroscopy 4-Evolution of brain volumes measured by MRI volumetry 5-White matter abnormalities on MRI measured by MRI, by anisotropy 6-HIV-CV> 50 copies / mL. Development of resistance mutations to any of the antiretrovirals used 7-Modification of HAART for another with different CNS penetration (exchange of CPE Score> ± 1); presence of virological failure, loss or removal of the monitoring from the study for any reason 8-Variation in the absolute levels of CD4 + 9-Levels of adherence to HAART, as measured by adherence questionnaire GEMMA 10-Number of general and specific adverse effects of CNS related and unrelated to HAART, and cumulative incidence of them;Timepoint(s) of evaluation of this end point: 1-From baseline to week 24 2-From baseline to week 24 3-From baseline to week 24 4-From baseline to week 24 5-From baseline to week 24 6-From baseline to week 24 7-From baseline to week 24 8-From baseline to week 24 9-Baseline and weeks 4, 12 and 24 10-Baseline and weeks 4, 12 and 24 | — |
Countries
Spain
Contacts
Public ContactMaria Yllescas
FIBHULP
Outcome results
None listed