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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00162097
The ClinicalTrials.gov registry entry for NCT00162097 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 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 (95% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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