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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

NCT04424264 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-06-07

No results posted yet for this study

Summary

This is a pharmacokinetic study investigating the effect of rifampicin on the pharmacokinetics of intracellular tenofovir-diphosphate and plasma tenofovir when coadministered with tenofovir alafenamide fumarate during the maintenance phase of tuberculosis treatment in TB/HIV-1 coinfected participants (EpiTAF)

Conditions

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

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • Professor Francois Venter

    lead OTHER

Principal Investigators

  • Simiso Sokhela, MBBCh · Ezintsha, a subdivision of Wits Reproductive Health and HIV Institute (Wits RHI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-05
Primary Completion
2020-10-30
Completion
2020-10-30

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

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 NCT04424264 on ClinicalTrials.gov