NCT04424264View on ClinicalTrials.gov

The Effect of Rifampicin on the Pharmacokinetics of Intracellular Tenofovir-diphosphate and Tenofovir When Coadministered With Tenofovir Alafenamide Fumarate During the Maintenance Phase of Tuberculosis Treatment in TB/HIV-1 Coinfected Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

December 5, 2019

Primary Completion Date

October 30, 2020

Study Completion Date

October 30, 2020

Conditions
HIV-1-infectionTuberculosis
Interventions
DRUG

Phase 1: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz coadministered with Rifampicin/Isoniazid

TDF/FTC/EFV 300/200/600 mg once daily plus RIF/INH 600\*/300 mg daily from screening until enrolment (days -15 to 0)

DRUG

Phase 2: Tenofovir alafenamide/Lamivudine/Efavirenz coadministered with Rifampicin/Isoniazid

TAF 25 mg + 3TC 300 mg + EFV 600 mg once daily plus RIF/INH 600/\*300 mg daily (days 1 to ≤ 56)

DRUG

Phase 3: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz

TDF/FTC/EFV 300/200/600 mg once daily. RIF/INH 600mg \<70kg, 750mg \>70kg

Trial Locations (2)

2196

Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg

Unknown

Wits RHI Yeoville Clinic, Johannesburg

All Listed Sponsors
collaborator

University of Cape Town

OTHER

lead

Professor Francois Venter

OTHER

NCT04424264 - The Effect of Rifampicin on the Pharmacokinetics of Intracellular Tenofovir-diphosphate and Tenofovir When Coadministered With Tenofovir Alafenamide Fumarate During the Maintenance Phase of Tuberculosis Treatment in TB/HIV-1 Coinfected Participants | Biotech Hunter | Biotech Hunter