A Phase III randomised, double-blind, multicentre study to evaluate the safety and efficacy of 1592U89 (abacavir) in human immunodeficiency virus 1-infected patients with aquired immune deficiency syndrome dementia complex
Completed
- Conditions
- HIV-1 infection with AIDS dementiaInfections and InfestationsHIV, AIDS
- Registration Number
- ISRCTN53707238
- Lead Sponsor
- GlaxoSmithKline (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Confirmed human immunodeficiency virus-1 (HIV-1) seropositive male or female subjects, aged 18 to 65 years, diagnosed with stage 1 or 2 (mild to moderate) AIDS dementia complex and stable on current antiretroviral therapy for a minimum of eight weeks prior to study entry were enrolled. Subjects were impaired by at least 1.5 standard deviations (SDs) below normal in at least two neuropsychological domains from the neuropsychological test battery
Exclusion Criteria
Subjects with evidence of confounding neurological disease or presenting with other central nervous system (CNS) opportunistic infections or neoplasms were excluded
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in neuropsychological performance.
- Secondary Outcome Measures
Name Time Method Reduction in cerebrospinal fluid HIV viral load.