Doravirine, Rifapentine and Isoniazid Interaction
Completed · Phase 1
Conditions studied: Latent Tuberculosis, Human Immunodeficiency Virus, Rifamycins Causing Adverse Effects in Therapeutic Use, Drug Interaction Potentiation
In brief
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.
Key facts
- Study ID
- NCT03886701
- Run by
- Walter K. Kraft
- People needed
- 11
- Starts
- 2019-04-22
- Expected to finish
- 2019-05-20
- Last updated by the study team
- 2020-03-27
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male or female between 18-60 years old at the time of screening.
- Have a Body Mass Index (BMI) > 19 and < 33.
- Weigh > 45 kg but < 120 kg.
- Non-smoker (tobacco or electronic cigarettes).
- Negative QuantiFERON-TB Gold at screening.
- Subjects who agree to abstain from alcohol consumption throughout the duration of the study.
- 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.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
You may not qualify if…
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, dermatologic, psychiatric abnormalities or neurological (including stroke and chronic seizure) diseases.
- >500 mL blood or plasma donation in the 6 weeks prior to study start
- Known anaphylactic or severe systemic reactions to any components of doravirine, rifapentine, isoniazid or pyridoxine.
- Positive HIV, Hepatitis B or Hepatitis C virus. Evidence of prior Hepatitis B infection and immunity is not exclusionary.
- Latent or active tuberculosis infection. Documented prior fully treated latent tuberculosis is not exclusionary.
- Females who are postpartum < 12 months.
- Current drug or alcohol abuse.
- 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.
- Unable to refrain from use of over-the-counter, prescription (unless determined appropriate by the investigator), herbal or natural products, vitamins or supplements, or grapefruit juice/grapefruit products.
- Any clinical significant findings on lab, ECG or physical exam at screening.
Where it is running
- Thomas Jefferson University Clinical Research Unit — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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