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Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02588287
Recruitment Status : Active, not recruiting
First Posted : October 27, 2015
Last Update Posted : January 18, 2020
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study evaluates the effect of sofosbuvir/ledipasvir (SOF/LDV) treatment on the pharmacokinetics (PK) and renal safety of tenofovir. Subjects receiving tenofovir-based antiretroviral therapy with human immunodeficiency virus (HIV) protease inhibitors (HIV PI/r) and initiating SOF/LDV treatment for Hepatitis C virus (HCV) will be invited to participate. The study consists of three visits: a screening visit and two abbreviated 4-hour pharmacokinetic visits (one before initiating SOF/LDV and a second approximately 4 weeks after initiating SOF/LDV).

Condition or disease Intervention/treatment Phase
Hepatitis C and HIV Coinfection Other: Blood draws for tenofovir PK, renal function Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir
Study Start Date : November 2015
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Tenofovir PK before and after SOF/LDV Other: Blood draws for tenofovir PK, renal function

Primary Outcome Measures :
  1. Change in area under the plasma concentration (AUC) of tenofovir [ Time Frame: 4 weeks ]
    Compare tenofovir AUC0-24 before and after administration of SOF/LDV

Secondary Outcome Measures :
  1. Change in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 14 weeks ]
    Compare eGFR calculated using Modification of Diet in Renal Disease (MDRD) equation before and after the addition of SOF/LDV.

  2. Change in concentrations of tenofovir-diphosphate [ Time Frame: 4 weeks ]
    Compare concentrations of tenofovir-diphosphate in peripheral blood mononuclear cells and red blood cells before and after the addition of SOF/LDV

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • On tenofovir and a ritonavir-boosted PI for at least 30 days initiating HCV treatment with SOF/LDV
  • HCV RNA <48 copies/mL at most recent clinic visit

Exclusion Criteria:

  • eGFR < 60 ml/min
  • history of renal disease
  • Pregnant or planning pregnancy
  • Any medical, social, or mental-health issue(s) that, in the opinion of the investigators, could interfere with study participation or the study outcomes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02588287

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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
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Principal Investigator: Jennifer Kiser, PharmD University of Colorado, Denver

Osinusi A, Townsend K, Nelson A, et al. Use of Ledipasvir/Sofosbuvir Fixed Dose Combination for Treatment of HCV Genotype-1 Infection in Patients Coinfected with HIV - Eradicate Study. 65th Annual Meeting of the American Association for the Study of Liver Diseases; November 7-11, 2014; Boston, MA.
German P, Garrison K, Pang PS, et al. Drug Interactions Between the anti-HCV Regimen Ledipasvir/Sofosbuvir and Ritonavir-Boosted Protease Inhibitors plus Emtricitabine/Tenofovir DF. CROI 2015; February 23-26, 2015; Seattle, WA.
Harvoni prescribing information, Gilead Sciences, Foster City, CA. March 2015. (Accessed April 10, 2015, at
Recommendations for Testing, Managing, and Treating Hepatitis C. April 2015. (Accessed April 10, 2015, at
Cope R, Pickering A, Glowa T, Faulds S, Veldkamp P, Prasad R. Majority of HIV/HCV Co-Infected Patients Require Antiretroviral Therapy Switch Prior to Use of Simeprevir (abstract 651). CROI 2015; February 23-26, 2015; Seattle, WA.
Langness J, Larson B, Rogers M, J. KJ. Readying HIV/HCV Coinfected Patients for HCV Treatment: Occurrence and Management of Antiviral Interactions (abstract 18). 16th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy; May 26-28, 2015; Washington, DC.

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Responsible Party: University of Colorado, Denver Identifier: NCT02588287    
Other Study ID Numbers: 15-0123
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis, Viral, Human
HIV Infections
Liver Diseases
Digestive System Diseases
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Parasitic Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents