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

PHASE2TerminatedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

February 27, 2021

Primary Completion Date

December 15, 2021

Study Completion Date

December 27, 2021

Conditions
HIV InfectionLTBI
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.

Trial Locations (10)

7700

University of Cape Town Lung Institute (UCTLI) CRS, Cape Town

7705

South African Tuberculosis Vaccine Initiative (SATVI) CRS, Cape Town

10330

Thai Red Cross AIDS Research Centre (TRC-ARC) CRS, Pathum Wan

77030

Houston AIDS Research Team CRS, Houston

94110

University of California HIV/AIDS CRS, San Francisco

Unknown

Gaborone CRS, Gaborone

Malawi CRS, Lilongwe

Milton Park CRS, Milton Park

HT-6110

GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS, Port-au-Prince

Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS, Port-au-Prince

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ViiV Healthcare

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH