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Doravirine, Rifapentine and Isoniazid Interaction

NCT03886701 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-03-27

Study results available
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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.

Conditions

  • Latent Tuberculosis
  • Human Immunodeficiency Virus
  • Rifamycins Causing Adverse Effects in Therapeutic Use
  • Drug Interaction Potentiation

Interventions

DRUG

Doravirine (DOR)

Non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 infection in adults in combination with other antiretroviral agents.

DRUG

Rifapentine (RPT)

Rifamycin anti-tuberculosis agent indicated for the treatment of latent and active tuberculosis infection.

DRUG

Isoniazid (INH)

Anti-tuberculosis agent indicated for the treatment of latent and active tuberculosis infection.

Sponsors & Collaborators

Principal Investigators

  • Walter K Kraft, MD · Sidney Kimmel Medical College at Thomas Jefferson University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2019-05-20
Completion
2019-05-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03886701 on ClinicalTrials.gov