Doravirine, Rifapentine and Isoniazid Interaction

• Status: Completed
• Trial end date: 2019-05-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Walter K. Kraft
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Isoniazid; Reverse Transcriptase Inhibitors; Rifampin; Rifapentine

Criteria

Inclusion Criteria:

1. Healthy male or female between 18-60 years old at the time of screening.

2. Have a Body Mass Index (BMI) > 19 and < 33.

3. Weigh > 45 kg but < 120 kg.

4. Non-smoker (tobacco or electronic cigarettes).

5. Negative QuantiFERON-TB Gold at screening.

6. Subjects who agree to abstain from alcohol consumption throughout the duration of the study.

7. 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.

8. 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:

1. History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, dermatologic, psychiatric abnormalities or neurological (including stroke and chronic seizure) diseases.

2. >500 mL blood or plasma donation in the 6 weeks prior to study start

3. Known anaphylactic or severe systemic reactions to any components of doravirine, rifapentine, isoniazid or pyridoxine.

4. Positive HIV, Hepatitis B or Hepatitis C virus. Evidence of prior Hepatitis B infection and immunity is not exclusionary.

5. Latent or active tuberculosis infection. Documented prior fully treated latent tuberculosis is not exclusionary.

6. Females who are postpartum < 12 months.

7. Current drug or alcohol abuse.

8. 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.

9. 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.

10. Any clinical significant findings on lab, ECG or physical exam at screening.