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

Completed · Phase 3

Conditions studied: AIDS Dementia Complex, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002163

Run by

Glaxo Wellcome

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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).
• Psychoactive drugs (at the investigator's discretion).
• Concurrent Treatment:
• Excluded:
• Treatment with radiation therapy within the first 12 weeks of the study.
• NOTE:
• With the exception of local treatment for Kaposi's sarcoma.
• Patients with any of the following prior conditions are excluded:
• Previous neurological disease unrelated to HIV infection.
• History of clinically apparent hepatitis within the last 6 months.
• History of clinically apparent pancreatitis in the last 6 months.

Where it is running

• 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

Full record on ClinicalTrials.gov

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