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

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:
• •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.
• •Prior Medication:
• •Excluded:
• •Treatment with cytotoxic chemotherapeutic agents within 1 month of entry.
• •Participation in investigational antiretroviral trials within the past 3 months.
• •HIV vaccine within the past 3 months.
• •Treatment with immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anticytokine agents, anti-oxidants or interferons within 1 month of study entry.
• •Nerve growth factor.
• •Prior Treatment:
• •Excluded:
• •Treatment with radiation therapy within 1 month of entry.
• •NOTE:
• •With the exception of local treatment for Kaposi's sarcoma.
• •Risk Behavior:
• •Excluded:
• •Current alcohol or illicit drug use which may interfere with the patient's ability to comply with the study protocol.
• •Required:
• •Stable antiretroviral treatment that has been ongoing for a minimum of 6 weeks prior to study entry, may or may not include ZDV.
• •Required:
• •Stable antiretroviral treatment for a minimum of 6 weeks prior to study entry.