NCT03435146View on ClinicalTrials.gov

Safety Tolerability DDI Short Course Treatment of LTBI Infection With High-dose Rifapentine and Isoniazid or Standard Isoniazid Preventive Therapy in HIV+ Patients (DOLPHIN & DOLPHIN TOO)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

January 18, 2018

Primary Completion Date

December 7, 2022

Study Completion Date

December 7, 2022

Conditions
Respiratory Tract InfectionsHIV Infections
Interventions
COMBINATION_PRODUCT

3HP plus DTG +2NRTIs

"* HIV treatment: DTG will be dosed as described above and will be given with daily TDF/FTC (Groups 1 and 2) or with TDF/3TC (Groups 3 and 4).~* LTBI treatment: 3HP will be given once-weekly for a total of 12 doses, with doses as follows:~Rifapentine: 900 mg; Isoniazid: 900 mg (Groups 1,2 and 4) Isoniazid at standard of care dosing (Group 3)"

Trial Locations (1)

1736

The Aurum Institute: Tembisa Clinical Research Centre, Tembisa

All Listed Sponsors
collaborator

Johns Hopkins University

OTHER

collaborator

University of California

OTHER

lead

The Aurum Institute NPC

OTHER

NCT03435146 - Safety Tolerability DDI Short Course Treatment of LTBI Infection With High-dose Rifapentine and Isoniazid or Standard Isoniazid Preventive Therapy in HIV+ Patients (DOLPHIN & DOLPHIN TOO) | Biotech Hunter | Biotech Hunter