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NCT00162097 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment
A Phase 1 study of HIV Infections and Hepatic Impairment, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 4
- Study locations
NCT00162097: Completed Phase 1 study of HIV Infections and Hepatic Impairment, sponsored by Bristol-Myers Squibb.
NCT00162097 is a Phase 1 study of HIV Infections and Hepatic Impairment that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 21 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00162097, a Phase 1 study of HIV Infections and Hepatic Impairment, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable antiretroviral regimens containing EFV, and having selected degrees of hepatic impairment or normal hepatic function.
Primary Outcome
Cmax was obtained directly from the concentration-time data.
Conditions Studied
Interventions
- DRUG efavirenz containing antiretroviral regimen
Study Locations (4)
Maryland
- Johns Hopkins University School Of Medicine - Baltimore
Texas
- Uthscsa - San Antonio
Virginia
- Virginia Commonwealth University Health Systems - Richmond
Other
- Local Institution - Milan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2004-11 |
| Est. Completion | 2008-03 |
| Phase | Phase 1 |
What the finished NCT00162097 record still lists
NCT00162097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which efavirenz containing antiretroviral regimen is the first listed.
NCT00162097 reports a single indexed study location in Maryland, Texas, Virginia.
Frequently Asked Questions
What is clinical trial NCT00162097 about?
NCT00162097 is a clinical study titled "Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment". The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable antiretroviral regimens containing EFV, and having selected degrees of hepatic impairment or normal hepatic function.
What is the current status of trial NCT00162097?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2004-11. Estimated completion is 2008-03.
What conditions does trial NCT00162097 study?
This clinical trial studies the following conditions: HIV Infections, Hepatic Impairment.
What interventions are being tested in trial NCT00162097?
The interventions under investigation include: efavirenz containing antiretroviral regimen (DRUG).
Who is sponsoring clinical trial NCT00162097?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00162097 being conducted?
This trial has 4 study locations across Maryland, Texas, Virginia. 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 NCT00162097's enrollment target sits among peer trials
21 482nd of 542 higher than 57 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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