The CogNaive Study: Assessing Changes in Neurocognitive Function in Treatment Naïve HIV-1 Positive Subjects
- Registration Number
- NCT00540137
- Lead Sponsor
- Imperial College London
- Brief Summary
The purpose of this study is to investigate the possibility of an association between changes in neurocognitive function, as measured by a computerised test battery, and the use of two different highly active antiretroviral therapy (HAART) regimens in treatment naïve HIV-1 infected subjects commencing antiretroviral therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
- HIV-1 infected males or females
- Signed informed consent
- No previous antiretroviral treatment
- Males with CD4+ lymphocyte count < 400 cells/ųL and females with CD4+ lymphocyte count < 250 cells/ųL
- Susceptible to all currently licensed nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs)
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NRTIs plus PI arm atazanavir/ritonavir atazanavir 300 mg once daily, ritonavir 100 mg once daily with a nucleoside backbone NRTIs plus NNRTI arm nevirapine nevirapine 400 mg once daily (after 12 weeks induction)with a nucleoside backbone
- Primary Outcome Measures
Name Time Method To assess changes in simple reaction time as measured by a computerised test battery over study period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Heart of England NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
St. Mary's Hospital
🇬🇧London, United Kingdom