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Antiretroviral Agent
Efavirenz for Drug Interaction
Phase < 1
Recruiting
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up methadone and tizanidine plasma concentrations (0-72 hours) will be determined before (control) and after pretreatment with efavirenz (600 mg/day) for 16 days and auc0-∞ will be estimated.
Awards & highlights
Study Summary
This trial will test the effect of a HIV-1 drug on how two other drugs, methadone and tizanidine, are processed by the body.
Who is the study for?
Healthy adults aged 18-65, who are non-smokers or willing to abstain from tobacco and marijuana, can join this trial. They must not take any interfering substances for two weeks before and during the study. Participants should have specific CYP2B6 genotypes (NM, IM, PM) without significant health issues as confirmed by screening tests.Check my eligibility
What is being tested?
The study examines how genetic differences in CYP2B6 affect the body's handling of methadone and tizanidine when taken with efavirenz. It involves healthy volunteers grouped by their metabolism rate (normal, intermediate, poor), testing drug interactions at baseline and after taking efavirenz for 17 days.See study design
What are the potential side effects?
Potential side effects may include digestive disorders that could alter drug absorption, low blood pressure risks with tizanidine use, allergic reactions to study drugs (efavirenz, tizanidine or methadone), and possible mental health impacts like depression or anxiety.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ methadone and tizanidine plasma concentrations (0-72 hours) will be determined before (control) and after pretreatment with efavirenz (600 mg/day) for 16 days and auc0-∞ will be estimated.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~methadone and tizanidine plasma concentrations (0-72 hours) will be determined before (control) and after pretreatment with efavirenz (600 mg/day) for 16 days and auc0-∞ will be estimated.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Magnitude of effects of CYP2B6 genotype and multiple doses of efavirenz on the: 1) stereoselective disposition of methadone; and 2) disposition and pharmacodynamics of tizanidine
Trial Design
2Treatment groups
Experimental Treatment
Group I: Efavirenz (treatment)Experimental Treatment1 Intervention
Each CYP2B6 normal metabolizer (NM) (*1/*1), intermediate metabolizer (IM) (*1/*6), and poor metabolizer (PM) (*6/*6, *6/*18, or *18/*18) group will be administered a single dose of methadone (10 mg) and a single dose of tizanidine (4 mg) orally simultaneously after 16-day oral treatment with 600 mg/day efavirez
Group II: Baseline (control)Experimental Treatment1 Intervention
Each CYP2B6 normal metabolizer (NM) (*1/*1), intermediate metabolizer (IM) (*1/*6), and poor metabolizer (PM) (*6/*6, *6/*18, or *18/*18) group will receive a single dose of methadone (10 mg) and a single dose of tizanidine (4 mg) orally simultaneously at baseline (control).
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
981,702 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
269 Previous Clinical Trials
247,052 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.I am willing to commit the required time for the study.I am not pregnant.I do not have serious heart, liver, or kidney disease.I have a history of seizures or currently experience them.I am sexually active and unwilling to use nonhormonal birth control methods.I have a stomach or intestine problem that affects how medicines work in my body.I am not on medications that affect how drugs are broken down in my body.I work night shifts and am taking efavirenz.I am a nonsmoker or willing to quit smoking and using tobacco or marijuana for the study duration.I am willing to dedicate the necessary time for this study.My CYP2B6 gene test shows I am a normal, intermediate, or poor metabolizer.
Research Study Groups:
This trial has the following groups:- Group 1: Efavirenz (treatment)
- Group 2: Baseline (control)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the minimum age requirement for this research exclude those below 65 years old?
"This study requires that potential participants are aged at least 18 and no older than 65, which fulfills the eligibility criteria."
Answered by AI
Does my profile qualify me to partake in this clinical investigation?
"Participants of this trial must be between the ages 18 and 65, with no known drug interactions. The research team is currently accepting up to 60 patients into this study."
Answered by AI
Is recruitment currently underway for this clinical trial?
"Affirmative, the information hosted on clinicaltrials.gov reports that this study is no longer recruiting participants. Initially posted in May 15th 2023 and last updated March 15th of the same year, it does not appear to be currently looking for candidates; however there are 9 other trials actively enrolling patients at present."
Answered by AI
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