An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts

Inclusion Criteria

Concurrent Medication:

Allowed:

• Prophylactic therapy for Pneumocystis carinii pneumonia (PCP); aerosol pentamidine is the preferred method.
• Maintenance anticonvulsant therapy following a seizure in the context of the AIDS dementia complex.
• Patients taking anticonvulsants should have their anticonvulsant blood levels measured prior to starting zidovudine (AZT) or with changes in AZT dosage.
• Phenytoin, carbamazepine, and valproic acid.
• Judicious use of benzodiazepams.
• For analgesia or fever, modest doses of aspirin, Tylenol, or ibuprofen.
• Use of major mood or central nervous system altering drugs is discouraged and should be documented.

Patients with the following are included:

• An estimated pre-illness IQ = or > 70.
• A general neurodiagnostic evaluation before entry which will include a computerized tomographic (CT) scan or magnetic resonance imaging (MRI) scan and a lumbar puncture.
• Stable or indolently progressive mucocutaneous Kaposi's sarcoma with < 25 lesions and onset of < 10 new lesions during the 30-day period prior to study entry.
• Chronic seizure disorders requiring anticonvulsant therapy as long as the seizures are not associated with a fixed neurologic deficit.
• A blood HIV culture and p24 antigen capture assay at the time of the lumbar puncture. A second p24 antigen assay on study entry. Informed consent form must be signed by the patient, legal guardian, or parent.

Active substance abuse that would limit a patient's cooperation or evaluation.

Exclusion Criteria

Co-existing Condition:

Patients with the following will be excluded from the study:

• Active, symptomatic AIDS-associated opportunistic infections requiring ongoing maintenance therapy.
• Persistent fever, active persistent diarrhea, or continued severe weight loss.
• Severe premorbid psychiatric illness.
• Confounding neurologic disease or deficit.
• Concurrent or previous central nervous system infections or neoplasms.
• Concurrent active neoplasms other than basal cell carcinoma of the skin and mucocutaneous Kaposi's sarcoma.

Concurrent Medication:

Excluded:

• Major psychotropic medication including tricyclic antidepressants, MAO inhibitors, phenothiazines, butyrophenones, barbiturates, or amphetamines.
• Cimetidine.
• Ranitidine.
• Probenecid.
• Indomethacin.
• Acyclovir (ACV) prophylaxis for recurrent Herpes simplex.

Patients with the following will be excluded from the study:

• Active, symptomatic AIDS-associated opportunistic infections requiring ongoing maintenance therapy.
• Persistent fever, active persistent diarrhea, or continued severe weight loss.
• Severe premorbid psychiatric illness.
• Confounding neurologic disease or deficit.
• Concurrent or previous central nervous system infections or neoplasms.
• Concurrent active neoplasms other than basal cell carcinoma of the skin and mucocutaneous Kaposi's sarcoma.

Prior Medication:

Excluded within 2 weeks of study entry or for greater than 2 weeks of therapy:

• Zidovudine (AZT).
• Patients must not have previously exhibited toxic reaction to AZT.
• Excluded within 30 days of study entry:
• Immunomodulators and biologic response modifiers, including systemic steroids.
• Any investigational agent.
• Cytotoxic chemotherapy for Kaposi's sarcoma.

Prior Treatment:

Excluded within 30 days of study entry:

• Radiation therapy.
• Excluded within 2 weeks of study entry:
• Blood transfusion.