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Gene test could prevent risky drug interactions in HIV patients

NCT ID NCT05789173

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study looks at how a person's genetic makeup and the HIV drug efavirenz change the way the body processes methadone and tizanidine. Sixty healthy volunteers will be grouped by their CYP2B6 gene type and take these drugs with and without efavirenz. The goal is to understand why some people may get too much or too little drug effect, which could lead to safer dosing in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methadone, Tizanidine, Efavirenz
What this could lead to
If successful, this could help doctors predict and avoid dangerous drug interactions in people taking efavirenz with methadone or tizanidine.
What could go wrong
This is an early-phase study in 60 healthy volunteers, not patients. Results may not apply to real-world clinical settings or people with HIV.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Subjects will be included in the study if participants: * are male and female (approximately 1:1) volunteers between the age of 18 and 65 years old * are judged healthy without any significant medical condition as determined by and decided from a pre-enrollment screening session that include medical history, laboratory tests such as blood and urine tests, vital signs, and an electrical tracing of the heartbeat (electrocardiogram, EKG). The pre-enrollment screening will be done no more than six weeks before the start of the study. * are able and willing to adhere to the study medication restrictions two weeks before initiating the study and during the conduct of the entire study. These will include refraining from taking any prescriptions medications, over-the-counter medications, and herbal, dietary, and alternative supplements that may interact with the metabolism of those study drugs at least 2 weeks prior to the start of the study and until study completion. * are nonsmoker or individuals willing to refrain from smoking or use of tobacco or marijuana for at least two weeks prior to and until the completion of the study. * are willing to commit the time requested for this study. Exclusion Criteria: * Subjects will be excluded from the study if participants: * are underweight (weigh less than 50 kg or 110 lb.) or overweight \[BMI greater than 32\]. Body mass index is calculated using height and weight to estimate how much body fat subjects have. * have laboratory results that do not fall in a healthy range * have an electrical tracing (baseline EKG readings) that are abnormal as decided by the study physician (medical doctor). * have history of intolerance, allergic reactions (e.g., rash) or other forms of hypersensitivities to any of the study medications (efavirenz, tizanidine or methadone). * Have a hemoglobin count below the normal range (male \<13.4 gm/dL: and female \<12 gm/dL) * have a positive pregnancy urine test (if female) obtained just prior to each study. * are sexually active, who is unable or unwilling to use an appropriate and effective method of birth control (for example barrier methods like diaphragms or condoms) to avoid the possibility of becoming pregnant * are night shift workers in which case taking efavirenz may interfere with their work. * have any significant health condition such heart, liver, or kidney disease * have history or current seizures which may lead to collapse. * have history or current mental illness (brain) such as feeling sad or unhappy, loss of interest in normal activities, worried or suicidality (thoughts about or an unusual preoccupation with ending own life) or suicide attempts. * have gastrointestinal (digestive) disorders such as persistent diarrhea or malabsorption that would interfere with the absorption of orally administered drugs. * have history or current psychiatric disorders such as depression, anxiety, or suicidality or suicide attempts that may be exacerbated by participation in the study * have a history of or current HIV infection or have a lifestyle that places participants at a higher risk for contracting HIV (e.g., drug abuse, excessive alcohol drinking, and having multiple sexual partners). * take more than 2 alcoholic drinks per day on a regular basis for two weeks prior to the study and unwilling to stop alcoholic drinks during the study * unwilling or unable to stop taking drugs of abuse, including tobacco products or marijuana, two weeks prior to and during the entire study period * have a systolic blood pressure lower than 70 mm Hg which may place subjects on high risk for tizanidine induced hypotension * have participated in a research study involving intensive blood sampling or have donated blood within the past two months. * are taking prescription medications, over-the-counter medications, herbal or dietary supplements, and alternative medicines that may interfere with the metabolism of the study drugs (e.g., inhibitors or inducers of CYP2B6 or CYP1A2) and are unable or unwilling to stop taking these medications two weeks prior to and during the entire study period. * are employees or students under supervision of any of the study investigators. * cannot state a good understanding of this study including risks and requirements * are unable to follow the rules of this study. * cannot or unwilling to commit the time requested for this study.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Indiana University School of Medicine

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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