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

• Status: Completed
• Trial end date: 2020-10-30
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Willem Daniel Francois Venter
• Collaborator: University of Cape Town
• Treatments: Efavirenz; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Isoniazid; Lamivudine; Rifampin; Tenofovir

Criteria

Inclusion Criteria:

1. Adult (≥ 18 years old) male or female

2. HIV-1 infected on TDF/FTC/EFV with HIV RNA < 50 copies/mL in the last three months

3. On TB treatment in the maintenance phase (RIF/INH) with at least one month of TB treatment needed for completion

4. Women of childbearing potential must not be pregnant or breastfeeding, with a negative pregnancy test at screening

5. 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

6. 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 Criteria:

1. Weight < 40 kg

2. Estimated creatinine clearance < 50 mL/min

3. 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

4. Chronic medical requirement for any drugs that are known to affect the PK of the study drugs

5. Active drug/alcohol abuser

6. History of allergy or hypersensivity to any of the study drugs

7. Currently enrolled in an investigational drug study or has participated in an investigational drug study within the 4 weeks before screening

8. Unable to comply with study protocol and study protocol restrictions