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12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF

NCT02605304 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-05-02

Study results available
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Summary

People who are infected with Hepatitis C Virus (HCV) have a great chance of being cured of the infection when they are treated with sofosbuvir. However, in some instances, treatment with sofosbuvir-containing therapy does not work. It is not known if people respond to retreatment with sofosbuvir, after it did not work the first time. There is an important need to understand retreatment options in those instances. This clinical trial was done to study the response to two different regimens, ledipasvir/sofosbuvir and ledipasvir/sofosbuvir with ribavirin, and to see if they are safe and well-tolerated in HCV-infected persons whose previous treatment with sofosbuvir had failed.

Conditions

  • HIV-1 Infection
  • Hepatitis C

Interventions

DRUG

Ledipasvir/sofosbuvir

Participants were prescribed one fixed dose tablet of LDV 90 mg/SOF 400 mg orally per day.

DRUG

Ribavirin

Based on weight at entry: For weight \<75 kg, participants were prescribed 1000 mg of RBV per day, divided into two doses to be taken orally. For weight ≥75 kg: participants were prescribed 1200 mg of RBV per day, divided into two doses to be taken orally.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • Annie Luetkemeyer, MD · University of California, San Francisco HIV/AIDS CRS

  • Jennifer J. Kiser, PharmD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-17
Primary Completion
2017-01-20
Completion
2017-03-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02605304 on ClinicalTrials.gov