Doravirine, Rifapentine and Isoniazid Interaction (NCT03886701) | Clinical Trial Compass
CompletedPhase 1
Doravirine, Rifapentine and Isoniazid Interaction
United States11 participantsStarted 2019-04-22
Plain-language summary
Drug therapy for persons living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) co-infected with latent tuberculosis infection (LTBI) is complex. Anti-tuberculosis drugs used to treat LTBI often induce drug metabolizing enzymes that share the same metabolic pathway as antiretroviral drugs used for those living with HIV/AIDS. This study evaluates the drug-drug interaction (DDI) potential of an antiretroviral drug when co-administered with a common anti-tuberculosis regimen of drugs.
Who can participate
Age range18 Years ā 60 Years
SexALL
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Inclusion criteria
ā. Healthy male or female between 18-60 years old at the time of screening.
ā. Have a Body Mass Index (BMI) \> 19 and \< 33.
ā. Weigh \> 45 kg but \< 120 kg.
ā. Non-smoker (tobacco or electronic cigarettes).
ā. Negative QuantiFERON-TB Gold at screening.
ā. Subjects who agree to abstain from alcohol consumption throughout the duration of the study.
ā. Female subjects of childbearing potential must demonstrate a urine beta-hCG consistent with non-pregnancy at the time of the screening visit and agree to the use (and/or have their partner use) of an acceptable method of birth-control at initial screening, during the time of the trial and until two weeks after the last dose of drug following the last treatment period.
ā. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Exclusion criteria
What they're measuring
1
Doravirine Maximum Concentration (Cmax)
Timeframe: Day 4 and 21 (Period 1 and 2): 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
2
Doravirine Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12)
Timeframe: Day 4 and 21 (Period 1 and 2): 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
3
Doravirine Oral Clearance (CL/F)
Timeframe: Day 4 and 21 (Period 1 and 2): 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
. History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, dermatologic, psychiatric abnormalities or neurological (including stroke and chronic seizure) diseases.
ā. \>500 mL blood or plasma donation in the 6 weeks prior to study start
ā. Known anaphylactic or severe systemic reactions to any components of doravirine, rifapentine, isoniazid or pyridoxine.
ā. Positive HIV, Hepatitis B or Hepatitis C virus. Evidence of prior Hepatitis B infection and immunity is not exclusionary.
ā. Latent or active tuberculosis infection. Documented prior fully treated latent tuberculosis is not exclusionary.
ā. Females who are postpartum \< 12 months.
ā. Current drug or alcohol abuse.
ā. Received study drug in another study within 4 weeks or within 5 half-lives, which ever occurring first, before first anticipated dose of study drug in this study.