A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex
- Conditions
- AIDS Dementia ComplexHIV Infections
- Registration Number
- NCT00002163
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
To evaluate the benefit of adding 1592U89 to current antiretroviral therapies for AIDS dementia complex and to assess the safety and tolerance of the treatment regimens.
- Detailed Description
Patients must be on stable antiretroviral treatment for at least 6 weeks prior to study entry and will then be stratified depending on whether their regimen contains zidovudine (ZDV). Each stratum will be randomized separately to receive 1592U89 or placebo for 12 weeks. For the subsequent 40 weeks, open-label 1592U89 will be offered.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Johns Hopkins Univ School of Medicine
🇺🇸Baltimore, Maryland, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Univ of Manitoba / Faculty of Medicine
🇨🇦Winnipeg, Manitoba, Canada
Wellesley Hosp
🇨🇦Toronto, Ontario, Canada
Columbia Univ / Sergievsky Ctr
🇺🇸New York, New York, United States
HIV Neurobehavioral Research Ctr
🇺🇸San Diego, California, United States
Washington Univ Med Ctr
🇺🇸St Louis, Missouri, United States
Univ of North Carolina School of Medicine
🇺🇸Chapel Hill, North Carolina, United States