Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following conditions or symptoms are excluded:
• •Grade 3 neuropathy, based on the Neuropathy Targeted Symptom.
• •Questionnaire, or patients with any moderate abnormality indicative of peripheral neuropathy including stocking loss of sensation (to sharp pain, light touch, or vibration), distal extremity weakness (\< 4/5), or absent ankle jerks.
• •History of present or past acute or chronic pancreatitis.
• •Active, symptomatic AIDS-defining opportunistic infection and requiring any ongoing maintenance therapy for confounding neurologic disease.
• •Severe premorbid psychiatric illness including bipolar illness, schizophrenia, and electroconvulsive therapy.
• •Previous neurological disease unrelated to HIV infection:
• •multiple sclerosis, documented stroke, degenerative disease.
• •Patients with chronic seizure disorders or head injury will only be excluded if the condition results in functional impairment or is likely to interfere with the evaluation.
• •Concurrent or previous central nervous system infections or neoplasms as revealed by Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) scan or cerebrospinal fluid analysis (such as toxoplasmosis, primary or metastatic Central Nervous System (CNS) lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, tuberculous Central Nervous System (CNS) infections, and untreated neurosyphilis).
• •Concurrent Medication:
• •Excluded:
• •Intravenous pentamidine. DHPG (Ganciclovir) should not be co-administered.
• •Monoamine oxidase (MAO) inhibitors, phenothiazines, butyrophenones, barbiturates, amphetamines.
• •Oral acidifying agents.
• •Patients with the following are excluded:
• •Neoplasms not specifically allowed.
• •Grade 3 neuropathy.
• •History of present or past acute or chronic pancreatitis.
• •Active, symptomatic AIDS-defining opportunistic infection.
• •Requiring any ongoing maintenance therapy for confounding neurologic disease.
• •Conditions listed under Exclusion Co-existing Conditions.
• •Prior Medication:
• •Excluded within 30 days of study entry:
• •Anti-HIV therapy other than zidovudine (AZT).
• •Biologic response modifiers.
• •Corticosteroids.
• •Drugs toxic to peripheral nerves.
• •Investigative drugs.
• •Neurotoxic drugs.
• •Excluded:
• •Dideoxycytidine (ddC).
• •Active alcohol or drug abuse or methadone maintenance sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy and evaluations.