HIV
Conditions
Interventions
Trade Name: Viramune
Product Name: Nevirapine
Pharmaceutical Form: Tablet
Trade Name: Reyataz
Product Name: Atazanavir
Sponsors
Imperial College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • HIV-1 infected males or females • signed informed consent • no previous antiretroviral treatment • males with CD4+ lymphocyte count =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • HLA*B-5701 haplotype positive • existing neurological disease • hepatitis B or hepatitis C co-infection • current history of major depression or psychosis • recent head injury • current alcohol abuse or drug dependence • active opportunistic infection or significant co-morbidities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the changes in simple reaction time of study period as measured by a computerised test battery;Secondary Objective: Proportion of subjects with an HIV RNA <5 copies, <50 copies, <400 copies/mL at each visit and changes in CD4+ lymphocyte count from baseline at each visit; Primary end point(s): Primary Endpoints • To assess changes in simple reaction time over study period as measured by a computerised test battery Secondary Endpoints • Proportion of subjects with an HIV RNA <5 copies/mL, <50 copies/mL and <400 copies/mL at each visit • Changes in CD4+ lymphocyte count from baseline at each visit • Genotypic resistance associated with virological failure • To assess the safety and tolerability of two once daily antiretroviral regimens be means of clinical and laboratory adverse events over 48 weeks • To assess changes in choice reaction time, complex reaction time, monitoring reaction time and other neurocognitive parameters over 48 weeks • Associations between changes in neurocognitive function over 48 weeks and ultra-ultra sensitive plasma HIV RNA • Associations between changes in neurocognitive function over 48 weeks and NNRTI / PI plasma concentration • Changes in lipid parameters baseline over 48 weeks MRS and LP sub-study Endpoints • Association between changes in CSF RNA over 48 weeks and changes in neurocognitive function and CNS metabolites measured by MRS • Association between changes in CNS metabolites as measured by MRS and neurocognitive function • Associations between changes in neurocognitive function and CNS metabolite concentration and CSF drug concentrations. • Association between baseline CSF HIV nef function and neurocognitive function | — |
Countries
United Kingdom
Outcome results
None listed