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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: Completed Phase 3 study of HIV Infections and AIDS Dementia Complex, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Est. Completion | 1990-02 |
| Phase | Phase 3 |
What the finished NCT00000709 record still lists
NCT00000709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower).
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 lists 12 locations in 8 states (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.
Learn More About Clinical Trials
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Where NCT00000709's enrollment target sits among peer trials
50 355th of 542 higher than 177 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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