Status:
COMPLETED
Randomized, Double-Blind, Placebo-Controlled Trial of Nimodipine for the Neurological Manifestations of HIV-1
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Miles
Glaxo Wellcome
Conditions:
AIDS Dementia Complex
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
PRIMARY: To assess the safety of nimodipine in the treatment of HIV-Associated Motor / Cognitive Complex (formerly AIDS dementia complex). To assess the systemic or central nervous system toxicities (...
Detailed Description
HIV-infected patients may develop a condition known as HIV-Associated Motor / Cognitive Complex (also known as AIDS dementia complex) that causes damage to the nervous system, particularly the brain a...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Alternative or additional antiretroviral agents if on a stable dose for 8 weeks prior to study entry.
- Isoniazid.
- Anticonvulsants.
- Benzodiazepines and antidepressants (provided dose is stable prior to study entry).
- Symptomatic therapies (e.g., analgesics, antihistamines, antiemetics, and antidiarrheal agents).
- Maintenance therapy with clarithromycin, azithromycin, amikacin, ethambutol, clofazimine, ciprofloxacin, and rifampin for disseminated Mycobacterium avium infection.
- Maintenance therapy for opportunistic infections (e.g., PCP, MAI, CMV).
Patients must have:
- Documented HIV infection.
- HIV-Associated Motor / Cognitive Complex.
- Acceptable neurological and neuropsychological impairment scores.
- Estimated premorbid IQ of 70 or greater, consistent with completion of the sixth grade or ability to read at the sixth grade level. Current ability to read and comprehend a newspaper or history of such ability will satisfy this criterion for patients whose formal education stopped before the sixth grade. For patients who are illiterate, ability to make change from a dollar for a combined purchase of two items or the history of such ability will satisfy this criterion. In the absence of a functional definition, an age-correlated scaled score of > 5 on the Vocabulary Subtest of the WAIS-R or WISC-R may be used to establish IQ.
- Ability to provide written informed consent.
Prior Medication:
Required:
- AZT for at least 12 weeks prior to study entry or any other approved antiretroviral agent (i.e., ddI or ddC) for at least 8 weeks prior to study entry, except in antiretroviral-intolerant patients who must be off antiretrovirals for at least 4 weeks.
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
June 1 1994
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00000738
End Date
June 1 1994
Last Update
November 4 2021
Active Locations (12)
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1
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
2
Northwestern University CRS
Chicago, Illinois, United States, 60611
3
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
4
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114