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NCT00668395 · ClinicalTrials.gov registry record · NA

Effects of CYP2B6 Genetic Polymorphisms on Efavirenz Pharmacokinetics

A NA study of HIV, sponsored by Indiana University.

Completed
Registry status
NA
Development phase
73
Enrollment target
2
Study locations

NCT00668395: Completed NA study of HIV, sponsored by Indiana University.

NCT00668395 is a NA study of HIV that has completed, run by Indiana University. The registered enrollment target is 73 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00668395, a NA study of HIV, has completed, sponsored by Indiana University.

COMPLETED
Registry status
NA
Development phase
73 participants
Enrollment target
2
Study locations

Study Summary

1. To see how the liver breaks down efavirenz by an enzyme called CYP2B6. It is suggested that when Efavirenz is taken repeatedly it may increase the amount of CYP2B6 in your liver and thus speed up your liver's ability to get rid of efavirenz from your body. This may render efavirenz and other medications ineffective. 2. To see how efavirenz interact with other drugs taken at the same time with it. 3. To see if genetic differences can change the way how the liver breaks down efavirenz and its interactions with other co-administered drugs.

Primary Outcome

Efavirenz clearance is a measure of rate of elimination of the drug from the body. We used this measure to evaluate differences in rate of elimination of efavirenz at a single dose and after multiple dosing within three CYP2B6 genotypes (CYP2B6\*1/\*1, \*1/\*6 and CYP2B6\*6/\*6). Efavirenz clearance was measured in normal metabolizer of CYP2B6 (CYP2B6\*1/\*1 genotype), intermediate metabolizer (CYP2B6\*1/\*6) and slow metabolizer (CYP2B6\*6/\*6) at a single 600 mg oral dose of efavirenz and then

Conditions Studied

Interventions

  • DRUG Efavirenz

Study Locations (2)

Indiana

  • Indiana Clinical Research Center (ICRC) - Indianapolis
  • Indiana University - Indianapolis

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2007-05
Est. Completion 2010-04
Phase NA
Indiana University

890 total trials

What the finished NCT00668395 record still lists

NCT00668395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (83% lower).

The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 1 intervention - of which Efavirenz is the first listed.

NCT00668395 reports a single indexed study location in Indiana.

Frequently Asked Questions

What is clinical trial NCT00668395 about?

NCT00668395 is a clinical study titled "Effects of CYP2B6 Genetic Polymorphisms on Efavirenz Pharmacokinetics". 1. To see how the liver breaks down efavirenz by an enzyme called CYP2B6. It is suggested that when Efavirenz is taken repeatedly it may increase the amount of CYP2B6 in your liver and thus speed up your liver's ability to get rid of efavirenz from your body. This may render efavirenz and other medi...

What is the current status of trial NCT00668395?

This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2007-05. Estimated completion is 2010-04.

What conditions does trial NCT00668395 study?

This clinical trial studies the following conditions: HIV.

What interventions are being tested in trial NCT00668395?

The interventions under investigation include: Efavirenz (DRUG).

Who is sponsoring clinical trial NCT00668395?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00668395 being conducted?

This trial has 2 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for HIV

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 NCT00668395's enrollment target sits among peer trials

73 189th of 303 higher than 115 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00668395, the US trial registry maintained by the National Library of Medicine. NCT00668395 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.