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Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV

NCT01443923 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2015-07-13

Study results available
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Summary

Background:

\- Standard treatment for the hepatitis C virus (HCV) is a combination of the drugs peg-IFN and ribavirin. However, this treatment is not very effective in people with a serious type of HCV (HCV genotype 1) and also in people who have human immunodeficiency virus (HIV) coinfection. Researchers want to add a new drug, boceprevir to see if it can improve treatment results in people with both HCV genotype 1 and HIV. Boceprevir used in combination with peg-IFN and ribavirin has been recently approved for the treatment of people with HCV genotype 1 infection only, and is currently being studied in those with HIV and HCV.

Objectives:

\- To test boceprevir, peg-IFN, and ribavirin as a treatment for HCV genotype 1 in people with HCV monoinfection compared to those with both HIV and HCV infections.

Eligibility:

* Individuals at least 18 years of age who have HCV genotype 1 infection, and have not received interferon treatment for HCV
* Half of the study participants will also have HIV infection.

Design:

* Participants will be screened with a medical history and physical exam. They will also have blood and urine tests.
* Participants will also have heart and liver function tests, and answer questions about mood and depression.
* Those in the study will receive ribavirin tablets to take twice a day, and peg-IFN to inject under the skin weekly.
* Two weeks after starting treatment, participants will have blood tests to study the treatment.
* Four weeks after starting treatment, participants will start taking boceprevir three times a day.
* Participants will have regular study visits with blood samples and other tests. The length of therapy will depend on the level of virus detected in the blood at several clinic visits. Those who do not respond well to the medicines at 12 weeks will stop treatment. The full length of treatment is 48 weeks.

Conditions

Interventions

DRUG

Boceprevir

DRUG

Peg-Interferon-alfa 2B

DRUG

Ribavirin

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Shyamasundaran Kottilil, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01443923 on ClinicalTrials.gov