Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF)
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 5/19/2018 |
| Start Date: | January 8, 2018 |
| End Date: | August 31, 2019 |
| Contact: | Jennifer J Kiser, PharmD |
| Email: | jennifer.kiser@ucdenver.edu |
| Phone: | 303-724-6131 |
Effects of Ledipasvir/Sofosbuvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF) in Patients With HIV.
This study will evaluate the effect of ledipasvir/sofosbuvir (LDV/SOF) treatment on the
pharmacokinetics (PK) and renal safety of tenofovir in the form of tenofovir alafenamide
(TAF). Subjects living with human immunodeficiency virus (HIV) who are receiving
tenofovir-based antiretroviral therapy (in the form of tenofovir disoproxil fumarate [TDF]),
and are also taking a ritonavir- or cobicistat-boosted protease inhibitor will be invited to
participate.
The study will consist of five visits: a screening visit, three abbreviated 4-hour
pharmacokinetic visits, and one end-of-study follow-up visit.
Subjects will also be asked to use a Wisepill device, which will track medication adherence
throughout the study.
pharmacokinetics (PK) and renal safety of tenofovir in the form of tenofovir alafenamide
(TAF). Subjects living with human immunodeficiency virus (HIV) who are receiving
tenofovir-based antiretroviral therapy (in the form of tenofovir disoproxil fumarate [TDF]),
and are also taking a ritonavir- or cobicistat-boosted protease inhibitor will be invited to
participate.
The study will consist of five visits: a screening visit, three abbreviated 4-hour
pharmacokinetic visits, and one end-of-study follow-up visit.
Subjects will also be asked to use a Wisepill device, which will track medication adherence
throughout the study.
Inclusion Criteria:
- Between 18-70 years of age
- Have been taking TDF and a ritonavir- or cobicistat-boosted protease inhibitor as part
of standard care for treatment of HIV
Exclusion Criteria:
- eGFR < 30 mL/min
- Pregnant or planning pregnancy
- Breastfeeding
- Any medical, social, or mental-health issue(s) that, in the opinion of the
investigators, could interfere with study participation or the study outcomes
- Signs or symptoms of decompensated liver disease
- Hepatitis B infection
- Medications that may cause unwanted drug interactions with ledipasvir/sofosbuvir or
emtricitabine/tenofovir alafenamide
- Unwillingness or inability to comply with study procedures
- Chronic hepatitis C infection
We found this trial at
1
site
12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
720-848-0000
Phone: 303-724-6131
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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