Phase 1
N=11
Doravirine, Rifapentine and Isoniazid Interaction
Latent Tuberculosis · Human Immunodeficiency Virus · Rifamycins Causing Adverse Effects in Therapeutic Use · Drug Interaction Potentiation
Bottom Line
View on ClinicalTrials.gov: NCT03886701 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Doravirine Maximum Concentration (Cmax) — 1.7; 1.3 ug/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Doravirine (DOR) (Drug); Rifapentine (RPT) (Drug); Isoniazid (INH) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Walter K. Kraft
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Doravirine Maximum Concentration (Cmax) |
1.7; 1.3 | — |
| PRIMARY Doravirine Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12) |
17.3; 12.3 | — |
| PRIMARY Doravirine Oral Clearance (CL/F) |
5.9; 8.4 | — |
| SECONDARY Adverse Event |
1; 0; 0; 1; 0; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy male or female between 18-60 years old at the time of screening.
- Have a Body Mass Index (BMI) > 19 and 45 kg but 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.
Data sourced from ClinicalTrials.gov (NCT03886701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.