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

Inclusion Criteria

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.