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COMPLETED Phase 1

Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment

NCT00162097 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 21 participants
Start Date 2004-11
Est. Completion 2008-03
Phase Phase 1

Sponsor

Bristol-Myers Squibb

504 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00162097 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Maryland, Texas, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00162097?

The interventions under investigation include: efavirenz containing antiretroviral regimen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00162097?

This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial