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NCT00000877 · ClinicalTrials.gov registry record · Phase 1
Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 8
- Study locations
NCT00000877 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 31 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The trial reports 8 study locations across 6 states.
The verdict
NCT00000877, 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
- 31 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to evaluate the safety of giving indinavir and rifabutin at the same time (simultaneously) vs 4 hours apart (staggered) to HIV-positive and HIV-negative adults. It is important to determine which medications for HIV-associated diseases, such as Mycobacterium avium complex (MAC) disease, can be given safely and effectively with anti-HIV drugs. Indinavir and rifabutin have been given simultaneously in the past with good results. This study seeks to examine if staggering the doses will make the 2 drugs more effective. HIV-negative volunteers are used in this study to examine the effect of rifabutin on indinavir and the effect of staggered rifabutin doses. The effect of rifabutin on the drug activity of indinavir is evaluated in HIV-positive patients.
Conditions Studied
Interventions
- DRUG Rifabutin
- DRUG Indinavir sulfate
Study Locations (8)
California
- Univ of Southern California / LA County USC Med Ctr - Los Angeles
- Univ of Southern California / LA County USC Med Cntr - Los Angeles
New York
- Bellevue Hosp / New York Univ Med Ctr - New York
- Cornell Univ Med Ctr - New York
Colorado
- Univ of Colorado Health Sciences Ctr - Denver
Florida
- Univ of Miami School of Medicine - Miami
Indiana
- Indiana Univ Hosp - Indianapolis
Maryland
- Johns Hopkins Hosp - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Est. Completion | 2000-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000877
The ClinicalTrials.gov registry entry for NCT00000877 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 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 (93% 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 2 interventions - of which Rifabutin is the first listed.
NCT00000877 reports 8 study locations spanning 6 distinct geographic areas - top geographies include California, New York, Colorado.
Frequently Asked Questions
What is clinical trial NCT00000877 about?
NCT00000877 is a clinical study titled "Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults". The purpose of this study is to evaluate the safety of giving indinavir and rifabutin at the same time (simultaneously) vs 4 hours apart (staggered) to HIV-positive and HIV-negative adults. It is important to determine which medications for HIV-associated diseases, such as Mycobacterium avium compl...
What is the current status of trial NCT00000877?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. Estimated completion is 2000-10.
What conditions does trial NCT00000877 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00000877?
The interventions under investigation include: Rifabutin (DRUG), Indinavir sulfate (DRUG).
Who is sponsoring clinical trial NCT00000877?
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 NCT00000877 being conducted?
This trial has 8 study locations across California, Colorado, Florida, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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