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NCT00000778 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin
A Phase 1 study of HIV Infections and Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 10
- Study locations
NCT00000778 is a Phase 1 study of HIV Infections and Tuberculosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 44 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (90% lower). The trial reports 10 study locations across 6 states.
The verdict
NCT00000778, a Phase 1 study of HIV Infections and Tuberculosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 10
- Study locations
Study Summary
To evaluate the methodology for rapidly determining the early bactericidal activity (EBA), tolerance, and pharmacokinetics of isoniazid and levofloxacin in the treatment of pulmonary tuberculosis (TB). Traditionally, in trials for treatment of TB, a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time. In this setting, it is difficult to determine the effect of any single drug or dose level. Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period. This study utilizes a method to measure the amount of bacteria present each day in the lungs.
Conditions Studied
Interventions
- DRUG Isoniazid
- DRUG Pyridoxine hydrochloride
- DRUG Levofloxacin
Study Locations (10)
Texas
- Univ of Texas Southwestern Med Ctr of Dallas - Dallas
- Univ TX Galveston - Galveston
- Baylor College of Medicine / Houston Veterans Adm Med Ctr - Houston
California
- UCLA Med Ctr - Los Angeles
- Harbor - UCLA Med Ctr - Torrance
Florida
- Broward Gen Med Ctr - Fort Lauderdale
- Univ of Miami / Jackson Memorial Hosp - Miami
Alabama
- Univ of Alabama at Birmingham - Birmingham
Illinois
- Univ of Illinois - Chicago
Louisiana
- Tulane Univ Med School - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000778
The ClinicalTrials.gov registry entry for NCT00000778 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 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 (90% 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 3 interventions - of which Isoniazid is the first listed.
NCT00000778 reports 10 study locations spanning 6 distinct geographic areas - top geographies include Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT00000778 about?
NCT00000778 is a clinical study titled "A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin". To evaluate the methodology for rapidly determining the early bactericidal activity (EBA), tolerance, and pharmacokinetics of isoniazid and levofloxacin in the treatment of pulmonary tuberculosis (TB). Traditionally, in trials for treatment of TB, a new drug is administered in combination with two ...
What is the current status of trial NCT00000778?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants.
What conditions does trial NCT00000778 study?
This clinical trial studies the following conditions: HIV Infections, Tuberculosis.
What interventions are being tested in trial NCT00000778?
The interventions under investigation include: Isoniazid (DRUG), Pyridoxine hydrochloride (DRUG), Levofloxacin (DRUG).
Who is sponsoring clinical trial NCT00000778?
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 NCT00000778 being conducted?
This trial has 10 study locations across Alabama, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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