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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Page 1 of 3 (12 locations)

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

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