MedTrace Logo

Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals

NCT04272242 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-09-19

Study results available
· View outcomes & findings →

Summary

This study evaluated the potential drug-drug interactions between dolutegravir (DTG) and steady state rifapentine (RPT) when RPT was given with isoniazid (INH) daily for 4 weeks (1HP) as part of treatment for latent TB infection (LTBI) in HIV-1 and LTBI co-infected individuals.

Conditions

  • HIV Infection
  • LTBI

Interventions

DRUG

Dolutegravir (DTG)

Administered orally

DRUG

Isoniazid (INH)

Administered orally

DRUG

Rifapentine (RPT)

Administered orally

DRUG

Antiretroviral Therapy (ART)

Participants remained on DTG-based ARV treatment with 2 NRTIs (excluding TAF) during the study. NRTIs were not provided by the study. Arm 1 participants took non-study supply of DTG for morning doses, and study-supplied DTG for evening doses. For Arm 2 participants, DTG was to have come from non-study ARV supply.

DIETARY_SUPPLEMENT

Pyridoxine (Vitamin B6)

Participants received 25 or 50 mg of pyridoxine (vitamin B6) with each dose of INH, based on the current local, national, or international dosing guidelines. Pyridoxine was not provided by the study.

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Anthony Podany, PharmD · University of Nebraska

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-27
Primary Completion
2021-12-15
Completion
2021-12-27
FDA Drug
Yes

Countries

  • United States
  • Botswana
  • Haiti
  • Malawi
  • South Africa
  • Thailand
  • Zimbabwe

Study Locations

More Related Trials

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 NCT04272242 on ClinicalTrials.gov