NCT02771249View on ClinicalTrials.gov

Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

June 3, 2016

Primary Completion Date

August 17, 2021

Study Completion Date

August 17, 2021

Conditions
HIV Infected Population With Latent Tuberculosis
Interventions
DRUG

rifapentene (RPT)

RPT is a long-acting rifamycin used in combination with INH in the treatment of LTBI.

DRUG

darunavir/cobicistat (DRV/c)

DRV is a protease inhibitor (PI) indicated in the treatment of HIV infection.33 DRV requires coadministration with RTV (100 mg once or twice daily) or COBI (150 mg daily), the latter of which has been coformulated into a fixed-dose tablet with DRV (DRV/c 800/150 mg).

DRUG

Isoniazid (INH)

INH is an antimycobacterial agent that can be used alone or in combination with RPT for the treatment of LTBI. Given with Pyridoxine (vitamin B6)

DIETARY_SUPPLEMENT

Pyridoxine

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Institutes of Health Clinical Center (CC)

NIH

NCT02771249 - Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers | Biotech Hunter | Biotech Hunter