Randomized, Double-Blind, Placebo-Controlled Trial of Nimodipine for the Neurological Manifestations of HIV-1
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 09, 2025
Completed
Keywords
ClinConnect Summary
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 and spinal cord. Evidence exists that nimodipine protects nerve cells in culture from injury by HIV. Although nimodipine has been used in patients with other neurological problems, its safety and effectiveness in halting the progression of HIV-Associated Motor / Cognitive Complex is not yet known.
Forty patients currently taking zidovudine (AZT) or any other approved antiretroviral agent will b...
Gender
ALL
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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Saint Louis, Missouri, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Seattle, Washington, United States
Patients applied
Trial Officials
Lipton S
Study Chair
Navia B
Study Chair
Simpson D
Study Chair
Tucker T
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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