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A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex

NCT00002163•Glaxo Wellcome

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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:
+34 more criteria

Locations (9)

HIV Neurobehavioral Research Ctr

San Diego, California, United States

San Francisco Gen Hosp

San Francisco, California, United States

Johns Hopkins Univ School of Medicine

Baltimore, Maryland, United States

Washington Univ Med Ctr

St Louis, Missouri, United States

Mount Sinai Med Ctr

New York, New York, United States

Columbia Univ / Sergievsky Ctr

New York, New York, United States

Univ of North Carolina School of Medicine

Chapel Hill, North Carolina, United States

Univ of Manitoba / Faculty of Medicine

Winnipeg, Manitoba, Canada

Wellesley Hosp

Toronto, Ontario, Canada

Key Dates

Last Updated

June 24, 2005

Conditions

AIDS Dementia ComplexHIV Infections

Interventions

Abacavir sulfate

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex

Inclusion Criteria

Exclusion Criteria

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