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NCT00000709 · ClinicalTrials.gov registry record · Phase 3

An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts

A Phase 3 study of HIV Infections and AIDS Dementia Complex, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 3
Development phase
50
Enrollment target
12
Study locations

NCT00000709 is a Phase 3 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 50 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower). The trial reports 12 study locations across 8 states.

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The verdict

NCT00000709, a Phase 3 study of HIV Infections and AIDS Dementia Complex, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
50 participants
Enrollment target
12
Study locations

Study Summary

To provide accurate and complete neurologic assessment of the course of the AIDS dementia complex in patients treated with zidovudine (AZT). The study will determine how frequently patients improve, how long improvement is sustained, and the magnitude and functional significance of improvement. Individuals with AIDS frequently suffer central nervous system (CNS) problems that are characterized by cognitive, motor, and behavioral deficits, in a disorder known as AIDS dementia complex. Clinical experience suggests that its course is often progressive, going from initial symptoms to moderate or severe dementia within several months. Accumulating evidence now suggests that direct brain infection by the HIV virus is the likely cause of the AIDS dementia complex. Case reports suggest that therapy with AZT, which has been shown to be a strong inhibitor of HIV replication in vitro, may alleviate the AIDS dementia complex. This study will help define the natural history of the AIDS dementia complex in treated patients.

Interventions

  • DRUG Zidovudine

Study Locations (12)

Louisiana

  • Charity Hosp / Tulane Univ Med School - New Orleans
  • Louisiana State Univ Med Ctr / Tulane Med School - New Orleans
  • Tulane Univ School of Medicine - New Orleans

New York

  • Bellevue Hosp / New York Univ Med Ctr - New York
  • Mem Sloan - Kettering Cancer Ctr - New York
  • Univ of Rochester Medical Center - Rochester

California

  • UCLA CARE Ctr - Los Angeles

Maryland

  • Johns Hopkins Hosp - Baltimore

North Carolina

  • Univ of North Carolina - Chapel Hill

Ohio

  • Univ Hosp of Cleveland / Case Western Reserve Univ - Cleveland

South Carolina

  • Julio Arroyo - West Columbia

Washington

  • Univ of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 50 participants
Est. Completion 1990-02
Phase Phase 3

What the Registry Record Tells You About NCT00000709

The ClinicalTrials.gov registry entry for NCT00000709 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 50 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 (89% 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 1 intervention - of which Zidovudine is the first listed.

NCT00000709 reports 12 study locations spanning 8 distinct geographic areas - top geographies include Louisiana, New York, California.

Frequently Asked Questions

What is clinical trial NCT00000709 about?

NCT00000709 is a clinical study titled "An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts". To provide accurate and complete neurologic assessment of the course of the AIDS dementia complex in patients treated with zidovudine (AZT). The study will determine how frequently patients improve, how long improvement is sustained, and the magnitude and functional significance of improvement. Ind...

What is the current status of trial NCT00000709?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. Estimated completion is 1990-02.

What conditions does trial NCT00000709 study?

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

What interventions are being tested in trial NCT00000709?

The interventions under investigation include: Zidovudine (DRUG).

Who is sponsoring clinical trial NCT00000709?

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 NCT00000709 being conducted?

This trial has 12 study locations across California, Louisiana, Maryland, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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