Status:
COMPLETED
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
Lead Sponsor:
Professor Francois Venter
Collaborating Sponsors:
University of Cape Town
Conditions:
HIV-1-infection
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 alafenamid...
Detailed Description
This is an open-label, sequential, single centre pharmacokinetic (PK) study investigating the effect of rifampicin on the pharmacokinetics of intracellular tenofovir-diphosphate and plasma tenofovir w...
Eligibility Criteria
Inclusion
- Adult (≥ 18 years old) male or female
- HIV-1 infected on TDF/FTC/EFV with HIV RNA \< 50 copies/mL in the last three months
- On TB treatment in the maintenance phase (RIF/INH) with at least one month of TB treatment needed for completion
- Women of childbearing potential must not be pregnant or breastfeeding, with a negative pregnancy test at screening
- Women must be postmenopausal, surgically sterile or practicing an effective birth control method (established before and maintained throughout the trial). Women who are not sexually active must agree to use an effective birth control method if they become heterosexually active during the trial
- Understand the purpose of and procedures required for the study and having confirmed they are willing to participate in the study by signing the informed consent document.
Exclusion
- Weight \< 40 kg
- Estimated creatinine clearance \< 50 mL/min
- Any active clinically significant or life-threatening disease (e.g. acute infections, pancreatitis, hepatitis, cardiac dysfunction), medical or psychiatric condition, or findings during screening, that in the investigator's opinion would compromise the safety of the participant or the study outcome, or their ability to comply with the study procedures
- Chronic medical requirement for any drugs that are known to affect the PK of the study drugs
- Active drug/alcohol abuser
- History of allergy or hypersensivity to any of the study drugs
- Currently enrolled in an investigational drug study or has participated in an investigational drug study within the 4 weeks before screening
- Unable to comply with study protocol and study protocol restrictions
Key Trial Info
Start Date :
December 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04424264
Start Date
December 5 2019
End Date
October 30 2020
Last Update
June 7 2022
Active Locations (2)
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1
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa, 2196
2
Wits RHI Yeoville Clinic
Johannesburg, Gauteng, South Africa