Effects of CYP2B6 Genetic Polymorphisms on Efavirenz Pharmacokinetics

Completed · Not applicable

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT00668395

Run by

Indiana University

People needed

73

Starts

2007-05-01

Expected to finish

2010-04-01

Last updated by the study team

2014-09-26

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female subjects between 18 and 49 years old.
• HIV negative. All potential subjects will be HIV tested at screening visit.
• Healthy individuals without any significant medical condition.
• Adherence to the study dietary restrictions.
• Nonsmoker or individuals willing to refrain from smoking or use of tobacco or marijuana for at lest one month prior to and until the completion of the study. The entire study lasts for 30 days.
• Ability to commit the time requested for this study.

You may not qualify if…

• History or current HIV infection.
• Life style that places you at a higher risk for contracting HIV (e.g. drug abuse, excessive alcohol drinking, and having multiple sexual partners).
• Does not consent to HIV testing.
• Underweight (weigh less than 52 kg or 114 lb) or overweight (body mass index (BMI) greater than 32).
• History or current alcohol or drug abuse (more than 3 alcoholic drinks per day on a regular basis).
• History of intolerance or allergic reaction (e.g. rash) to efavirenz, midazolam, tolbutamide, caffeine, or omeprazole.
• History or current significant health conditions such as heart, liver, or kidney.
• History or current psychiatric illness such as depression, anxiety, or nervousness.
• History or current gastrointestinal disorders such as persistent diarrhea or malabsorption that would interfere with the absorption of orally administered drugs.
• Individuals having a serious infection within the last month.
• Donation of blood within the past two months.
• Blood hemoglobin less than 12.5 mg/dl.
• Individuals who are regularly taking prescriptions, over-the-counter, herbal or dietary supplements, alternative medications, or hormonal agents (i.e. oral contraceptives, intera-uterine device with hormones).
• Females with a positive pregnancy test.
• Breastfeeding.
• Females of child-bearing potential who are unable or unwilling to either practice abstinence or use two non-hormonal forms of birth control (e.g. condom, contraceptive foams) up until the study completion, which will take a total of 30 days.
• Participation in a research study or use of an investigational drug in the last two months.
• An employee or student under supervision of any of the investigators of this study.
• Individuals who cannot state a good understanding of this study including risks and requirements; are unable to follow the rules of this study.
• Individuals with a gene type (DNA) that does not match one of the available genetic slot categories.

Where it is running

• Indiana Clinical Research Center (ICRC) — Indianapolis, Indiana, United States
• Indiana University — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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