A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection

Inclusion Criteria

Concurrent Medication:

Allowed:

• Aspirin, in modest doses.
• Ibuprofen, in modest doses.
• Maintenance antibiotic therapy posttherapy for an AIDS-defining opportunistic infection.

Concurrent Treatment:

Allowed:

• Blood transfusion if cardiovascular status is compromised.

Exclusion Criteria

• Active substance abuse.

Co-existing Condition:

Patients with the following conditions will be excluded:

• Concurrent or previous central nervous system infections or neoplasms.
• Active AIDS-defining opportunistic infection.
• Severe premorbid psychiatric illness.
• Confounding neurological disease.
• Concurrent neoplasms.

Concurrent Medication:

Excluded:

• Maintenance methadone or naltrexone.
• Acetaminophen.
• Mood- or central nervous system-altering drugs.
• Zidovudine for Pneumocystis carinii pneumonia (PCP).
• Acyclovir.
• Rifampin or derivatives.
• Drugs with antiretroviral activity.
• Experimental agents.

The following patients will be excluded from the study:

• Patients requiring ongoing therapy for an AIDS-defining opportunistic infection.
• Patients with a history of Mycobacterium avium intracellulare infection.
• Patients with a history of Pneumocystis carinii pneumonia infection.
• Patients with a daily temperature of 38 degrees C or more for 1 month.

Prior Medication:

Excluded:

• Zidovudine (AZT).
• Excluded within 14 days of study entry:
• Systemic anti-infectives.
• Excluded within 30 days of study entry:
• Immunomodulators and biologic response modifiers.
• Any investigational agent.
• Cytotoxic chemotherapy for Kaposi's sarcoma.

Prior Treatment:

Excluded:

• Radiation therapy.

Patients must demonstrate the following clinical and laboratory findings:

• No currently active AIDS-defining opportunistic infections.
• One negative blood culture for Mycobacterium avium intracellulare within 4-6 weeks prior to study entry.
• Constitutionally well without persistent fever.
• Less than 25 Kaposi's sarcoma lesions and less than 10 new lesions during the 30 days prior to study entry. Patients may have stable or indolently progressive mucocutaneous Kaposi's sarcoma.
• Characteristic clinical symptoms and signs of AIDS dementia complex.
• Abnormalities on 2 or more of 7 neuropsychological motor tests in the Neurological Screening Battery.
• Estimated premorbid IQ equal to or greater than 70 (+ or - 5), which is consistent with completion of sixth grade.