A randomised prospective study assessing changes in neuro-cognitive function, using a computerised test battery, in treatment naïve HIV-1 positive subjects commencing two different antiretroviral regimens. - CogNaive Study
- Conditions
- HIV
- Registration Number
- EUCTR2007-002405-47-GB
- Lead Sponsor
- Imperial College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
•HIV-1 infected males or females
•signed informed consent
•no previous antiretroviral treatment
•males with CD4+ lymphocyte count < 400 cells/uL and females with CD4+ lymphocyte count < 250 cells/uL
•susceptible to all currently licensed NRTIs, NNRTIs and PIs based on HIV-1 genotypic resistance
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method