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NCT00245986 · ClinicalTrials.gov registry record · Phase 4
Effect of Genetics on Metabolism of Efavirenz
A Phase 4 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 4
- Development phase
- 350
- Enrollment target
NCT00245986: Completed Phase 4 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00245986 is a Phase 4 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 350 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00245986, a Phase 4 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 350 participants
- Enrollment target
Study Summary
This study will evaluate the effects of genetics on metabolism of the anti-HIV medicine efavirenz (Sustiva) and will see if Efavirenz interacts with bupropion (Zyban or Wellbutrin), a drug commonly used to treat depression and to help people quit smoking. Efavirenz is metabolized by an enzyme called CYP2B6, which is thought to be more active in some people than in others, depending on their genetic makeup. The rate of metabolism of the drug can affect how the body responds it and perhaps the ability of the HIV virus to develop resistance to it. Healthy volunteers between 18 and 55 years of age who are non-smokers and HIV-infected men and women 18 years of age and older who are taking efavirenz along with two or three nucleoside reverse transcriptase inhibitors may be eligible for this study. Candidates are screened with a medical history and physical examination and blood tests, including tests to determine which genes they have for four different proteins or enzymes (CYP2B6, CYP3A4, CYP3A5, and MDR1) that metabolize drugs. Participants are assigned to one of three groups for the following procedures: -HIV-infected individuals: Blood samples are drawn to measure efavirenz levels, as follows: On the last day of taking efavirenz, the subject skips his or her usual evening efavirenz dose the night before sampling. The next morning at clinic, a catheter (flexible plastic tube) is inserted into a vein in the subject's arm for collecting blood samples. After the first sample is drawn, the subject takes a dose of efavirenz. Eight more blood samples are collected at 1, 2, 4, 6, 8, 12, 24 and 48 hours after taking the efavirenz tablet. (The catheter is removed after the 12-hour sample and the subject is discharged home, and then returns to the clinic for the 24- and 48-hour samples, which are collected through a needle inserted into an arm vein.) The subject returns to the clinic four more times for a single blood draw at 7, 14, 21 and 28 days after stopping efavirenz. H
Interventions
- PROCEDURE Blood draw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2005-10-18 |
| Est. Completion | 2008-05-20 |
| Phase | Phase 4 |
What the finished NCT00245986 record still lists
NCT00245986 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 1 intervention - of which Blood draw is the first listed.
NCT00245986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00245986 about?
NCT00245986 is a clinical study titled "Effect of Genetics on Metabolism of Efavirenz". This study will evaluate the effects of genetics on metabolism of the anti-HIV medicine efavirenz (Sustiva) and will see if Efavirenz interacts with bupropion (Zyban or Wellbutrin), a drug commonly used to treat depression and to help people quit smoking. Efavirenz is metabolized by an enzyme called...
What is the current status of trial NCT00245986?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 350 participants. The study started on 2005-10-18. Estimated completion is 2008-05-20.
What interventions are being tested in trial NCT00245986?
The interventions under investigation include: Blood draw (PROCEDURE).
Who is sponsoring clinical trial NCT00245986?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00245986's enrollment target sits among peer trials
350 231st of 2000 higher than 1,761 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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