A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex
2 other identifiers
interventional
N/A
2 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- Documented HIV infection.
- Evidence of HIV - associated dementia.
- Been on stable antiretroviral treatment for a minimum of 6 weeks prior to study entry.
You may not qualify if:
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Debilitated as a result of their HIV disease, associated illness or therapies who the investigator determines will not be able to complete the 12 week randomized dosing period.
- Memorial Sloan-Kettering (MSK) score of \>= 3 for dementia.
- Confounding neurological diseases which may interfere with interpretation of neurological and neurophysical assessments.
- Malabsorption syndrome or other gastrointestinal dysfunction which renders them unable to take oral medication.
- Chronic diseases such as diabetes, congestive heart failure, cardiomyopathy, other cardiac dysfunctions, etc., which in the investigator's opinion would compromise the safety of the patient.
- Symptomatic AIDS-defining opportunistic infection not responsive to therapy.
- Concurrent Medication:
- Excluded:
- Treatment with cytotoxic chemotherapeutic agents within the first 12 weeks of the study.
- Treatment with nerve growth factor within the first 12 weeks of study.
- The use of narcotic analgesics, sedatives, benzodiazepines, antidepressants, anti-psychotic agents and other psychoactive drugs which would interfere with the assessment of the neurological and neurophysical status of the patient.
- Use of stavudine (d4T) during the first 12 weeks of the study.
- Immunomodulating agents (except GM/G-CSF or epoietin).
- +29 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (9)
HIV Neurobehavioral Research Ctr
San Diego, California, 92103, United States
San Francisco Gen Hosp
San Francisco, California, 94110, United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21287, United States
Washington Univ Med Ctr
St Louis, Missouri, 63110, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Columbia Univ / Sergievsky Ctr
New York, New York, 10032, United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599, United States
Univ of Manitoba / Faculty of Medicine
Winnipeg, Manitoba, Canada
Wellesley Hosp
Toronto, Ontario, Canada
Related Publications (1)
Lanier ER, Sturge G, McClernon D, Brown S, Halman M, Sacktor N, McArthur J, Atkinson JH, Clifford D, Price RW, Simpson D, Torres G, Catalan J, Marder K, Power C, Hall C, Romero C, Brew B. HIV-1 reverse transcriptase sequence in plasma and cerebrospinal fluid of patients with AIDS dementia complex treated with Abacavir. AIDS. 2001 Apr 13;15(6):747-51. doi: 10.1097/00002030-200104130-00010.
PMID: 11371689BACKGROUND