CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 11 enrolled
Drug / intervention
Doravirine (DOR) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03886701
NCT03886701Phase 1Completed

A Phase 1, Open-Label, Fixed-Sequence, Drug Interaction Study to Investigate the Effect of Once-Weekly Rifapentine and Isoniazid on the Pharmacokinetics of Steady-State Doravirine

Walter K. Kraft·interventional·Posted Mar 22, 2019·Updated Mar 27, 2020

In Brief

A Phase 1 clinical trial evaluating Doravirine (DOR), Rifapentine (RPT), and 1 other intervention for Latent Tuberculosis and 3 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedMar 22, 2019
Enrollment StartApr 22, 2019
Primary CompletionMay 20, 2019
TodayJul 2, 2026
Enrollment to primary: 28 daysPosted 7.3 years ago

Interventions

Doravirine (DOR)drug

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

Rifapentine (RPT)drug

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

Isoniazid (INH)drug

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