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NCT00992069 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Effect of TMC207 and Efavirenz in Healthy Volunteers
A Phase 1 study of HIV and Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 5
- Study locations
NCT00992069: Completed Phase 1 study of HIV and Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00992069 is a Phase 1 study of HIV and Tuberculosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 37 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00992069, a Phase 1 study of HIV and Tuberculosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 5
- Study locations
Study Summary
Common treatments for tuberculosis (TB) can interfere with certain antiretroviral (ARV) medications used to treat HIV. People whose immune systems are weakened by HIV infection are susceptible to TB, so it is important to find treatments for both that can be given in combination. This study will test the safety of combining a new medication for TB with an already approved HIV medication in healthy adults.
Conditions Studied
Interventions
- DRUG Efavirenz (EFV)
- DRUG TMC207
Study Locations (5)
California
- Ucsf Aids Crs - San Francisco
Maryland
- Johns Hopkins Adult AIDS CRS - Baltimore
North Carolina
- Unc Aids Crs - Chapel Hill
Ohio
- The Ohio State Univ. AIDS CRS - Columbus
Tennessee
- Vanderbilt Therapeutics CRS - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
What the finished NCT00992069 record still lists
NCT00992069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions - of which Efavirenz (EFV) is the first listed.
NCT00992069 lists 5 locations in 5 states (California, Maryland, North Carolina).
Frequently Asked Questions
What is clinical trial NCT00992069 about?
NCT00992069 is a clinical study titled "Safety, Tolerability, and Effect of TMC207 and Efavirenz in Healthy Volunteers". Common treatments for tuberculosis (TB) can interfere with certain antiretroviral (ARV) medications used to treat HIV. People whose immune systems are weakened by HIV infection are susceptible to TB, so it is important to find treatments for both that can be given in combination. This study will tes...
What is the current status of trial NCT00992069?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2009-12. Estimated completion is 2010-12.
What conditions does trial NCT00992069 study?
This clinical trial studies the following conditions: HIV, Tuberculosis.
What interventions are being tested in trial NCT00992069?
The interventions under investigation include: Efavirenz (EFV) (DRUG), TMC207 (DRUG).
Who is sponsoring clinical trial NCT00992069?
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 NCT00992069 being conducted?
This trial has 5 study locations across California, Maryland, North Carolina, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00992069's enrollment target sits among peer trials
37 248th of 303 higher than 54 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV 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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