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:
- 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.
Purpose
