Randomized, Double-Blind, Placebo-Controlled Trial of Nimodipine for the Neurological Manifestations of HIV-1

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following symptoms and conditions are excluded:
• •Active symptomatic AIDS-defining opportunistic infection (maintenance therapy for opportunistic infections, e.g., Pneumocystis carinii pneumonia, Mycobacterium avium infection, and cytomegalovirus, is permitted).
• •Neoplasms other than basal cell carcinoma, in situ carcinoma of the cervix, or Kaposi's sarcoma without evidence of visceral involvement or that do not require systemic chemotherapy.
• •Confounding neurological disorders, including the following:
• •a) neurologic disease unrelated to HIV infection (such as multiple sclerosis, documented stroke, degenerative disease); b) chronic seizure disorders or head injuries if the condition results in functional impairment or is likely to interfere with evaluations; c) central nervous system (CNS) infections or neoplasms (such as toxoplasmosis, primary or metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, tuberculous CNS infections, or untreated neurosyphilis).
• •Severe premorbid psychiatric illness including bipolar illness, schizophrenia, and depression requiring electroconvulsive therapy.
• •Major depression likely to interfere with evaluation or protocol compliance.
• •Concurrent Medication:
• •Excluded:
• •Major psychotropic medication, including MAO inhibitors, phenothiazines, butyrophenones, barbiturates, or amphetamines (unless a stable dose is maintained for 30 days prior to study entry).
• •Any ongoing maintenance therapy for confounding neurological disorders.
• •Patients with the following prior conditions are excluded:
• •Confounding neurological disorders defined in the "Exclusion Co-existing Conditions" field.
• •Prior Medication:
• •Excluded:
• •Investigative drugs within 30 days prior to study entry.
• •Confounding calcium channel antagonists (such as nifedipine, verapamil, diltiazem, and related drugs) within 4 weeks prior to study entry.
• •Active alcohol or drug abuse.