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NCT00000810 · ClinicalTrials.gov registry record · Phase 1
Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 10
- Study locations
NCT00000810 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 120 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower). The trial reports 10 study locations across 9 states.
The verdict
NCT00000810, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 10
- Study locations
Study Summary
PRIMARY: To study the safety and tolerance of delavirdine mesylate ( U-90152 ) monotherapy. To compare the anti-HIV activity of three blood concentration levels of this agent with nucleoside analog monotherapy, either zidovudine ( AZT ) or didanosine ( ddI ), based on the reduction of HIV viral burden. SECONDARY: To use pharmacokinetic parameters to assess the relationship between daily drug exposure and antiviral activity and toxicity of the U-90152, AZT, and ddI monotherapy. To assess anti-HIV activity using other disease markers. Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Didanosine
- DRUG Delavirdine mesylate
Study Locations (10)
New York
- SUNY - Buffalo, Erie County Medical Ctr. - Buffalo
- Univ. of Rochester ACTG CRS - Rochester
California
- Stanford CRS - Stanford
Colorado
- University of Colorado Hospital CRS - Aurora
District of Columbia
- Howard University Hosp., Div. of Infectious Diseases, ACTU - Washington D.C.
Florida
- Univ. of Miami AIDS CRS - Miami
Illinois
- Northwestern University CRS - Chicago
Indiana
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic - Indianapolis
North Carolina
- Unc Aids Crs - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Est. Completion | 1996-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000810
The ClinicalTrials.gov registry entry for NCT00000810 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 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 (73% 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 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Zidovudine is the first listed.
NCT00000810 reports 10 study locations spanning 9 distinct geographic areas - top geographies include New York, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT00000810 about?
NCT00000810 is a clinical study titled "Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)". PRIMARY: To study the safety and tolerance of delavirdine mesylate ( U-90152 ) monotherapy. To compare the anti-HIV activity of three blood concentration levels of this agent with nucleoside analog monotherapy, either zidovudine ( AZT ) or didanosine ( ddI ), based on the reduction of HIV viral burd...
What is the current status of trial NCT00000810?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. Estimated completion is 1996-01.
What conditions does trial NCT00000810 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00000810?
The interventions under investigation include: Zidovudine (DRUG), Didanosine (DRUG), Delavirdine mesylate (DRUG).
Who is sponsoring clinical trial NCT00000810?
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 NCT00000810 being conducted?
This trial has 10 study locations across California, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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