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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: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00000877 record still lists
NCT00000877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower).
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 lists 8 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00000877's enrollment target sits among peer trials
31 425th of 542 higher than 118 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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