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Drug Interaction Study With Ribavirin and Abacavir in Male Subjects With Hepatitis C Who Have Failed Ribavirin Treatment

NCT01052701 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-05-01

Study results available
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Summary

This research is being done to find out whether abacavir (Ziagen®) lowers the levels of ribavirin (Ribapak®) in the body of persons taking these two drugs.

Conditions

  • Hepatitis C
  • HIV

Interventions

DRUG

Ribavirin

Daily Ribavirin alone 400 mg in the morning (AM) and 600 mg in the afternoon (PM) orally with 12 hours between the doses (Body Weight ≤75 kg) OR Daily RBV alone 600 mg orally every 12 hours (Body Weight \>75 kg)

DRUG

Ribavirin plus Abacavir (ABC)

Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg) OR Daily RBV 600 mg orally every 12 hours (Body Weight \>75 kg) Plus Daily Abacavir 300 mg orally every 12 hours

Sponsors & Collaborators

Principal Investigators

  • Adriana Andrade, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01052701 on ClinicalTrials.gov