Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF)

PHASE4CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

January 8, 2018

Primary Completion Date

July 12, 2019

Study Completion Date

October 1, 2019

Conditions
Hepatitis CHIV Coinfection
Interventions
DRUG

TDF with a boosted protease inhibitor

"Participants who are already taking tenofovir disoproxil fumarate 300 mg (in the form of Viread or Truvada) in combination with either a ritonavir- or cobicistat-boosted protease inhibitor for HIV treatment will continue to take their prescribed treatment for 12 weeks after enrollment.~Other: Blood draws for tenofovir PK, renal function assessment"

DRUG

TAF with a boosted protease inhibitor

"Participants will be switched from tenofovir disoproxil fumarate to tenofovir alafenamide 25 mg/emtricitabine 200 mg with a boosted protease inhibitor.~Other: Blood draws for tenofovir PK, renal function assessment"

DRUG

TAF with a boosted protease inhibitor and LDV/SOF

"After taking tenofovir alafenamide/emtricitabine for 12 weeks, participants will then start taking ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) in combination with the tenofovir alafenamide 25 mg/emtricitabine 200 mg (Descovy) and a boosted protease inhibitor for 4 weeks. Subjects will then return to taking tenofovir alafenamide 25 mg/emtricitabine 200 mg (Descovy) and a boosted protease inhibitor for the final 12 weeks.~Other: Blood draws for tenofovir PK, renal function assessment"

Trial Locations (1)

80045

University of Colorado Hospital, Aurora

All Listed Sponsors
lead

University of Colorado, Denver

OTHER

NCT03126370 - Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF) | Biotech Hunter | Biotech Hunter