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NCT00000738 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of HIV Infections and AIDS Dementia Complex, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
12
Study locations

NCT00000738 is a Phase 1 study of HIV Infections and AIDS Dementia Complex that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 36 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (92% lower). The trial reports 12 study locations across 10 states.

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The verdict

NCT00000738, a Phase 1 study of HIV Infections and AIDS Dementia Complex, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
12
Study locations

Study 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 (e.g., rash, headache, gastrointestinal symptoms, nausea, dyspnea, muscle pain or cramp, acne) of nimodipine. SECONDARY: To assess the efficacy of nimodipine in stabilizing the progression of HIV-Associated Motor / Cognitive Complex by improvement in neuropsychological test performance, peripheral neuropathy, or other neurologic manifestations. 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.

Conditions Studied

HIV Infections AIDS Dementia Complex

Interventions

  • DRUG Zidovudine
  • DRUG Nimodipine

Study Locations (12)

Massachusetts

  • Massachusetts General Hospital ACTG CRS - Boston
  • Bmc Actg Crs - Boston
  • Beth Israel Deaconess - East Campus A0102 CRS - Boston

California

  • UCLA CARE Center CRS - Los Angeles

Illinois

  • Northwestern University CRS - Chicago

Indiana

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic - Indianapolis

Minnesota

  • University of Minnesota, ACTU - Minneapolis

Missouri

  • Washington U CRS - St Louis

New York

  • Univ. of Rochester ACTG CRS - Rochester

North Carolina

  • Unc Aids Crs - Chapel Hill

Trial Details

FieldValue
Enrollment Target 36 participants
Est. Completion 1994-06
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00000738

The ClinicalTrials.gov registry entry for NCT00000738 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (92% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Zidovudine is the first listed.

NCT00000738 reports 12 study locations spanning 10 distinct geographic areas - top geographies include Massachusetts, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT00000738 about?

NCT00000738 is a clinical study titled "Randomized, Double-Blind, Placebo-Controlled Trial of Nimodipine for the Neurological Manifestations of HIV-1". 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 (e.g., rash, headache, gastrointestinal symptoms, nausea, dyspnea, muscle pain or cramp, acne) of nim...

What is the current status of trial NCT00000738?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. Estimated completion is 1994-06.

What conditions does trial NCT00000738 study?

This clinical trial studies the following conditions: HIV Infections, AIDS Dementia Complex.

What interventions are being tested in trial NCT00000738?

The interventions under investigation include: Zidovudine (DRUG), Nimodipine (DRUG).

Who is sponsoring clinical trial NCT00000738?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00000738 being conducted?

This trial has 12 study locations across California, Illinois, Indiana, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.