BOC-HIV: HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin

Sponsor

Anna Cruceta (Other)

Overall Status

Completed

CT.gov ID

NCT01718301

Collaborator

(none)

128

Enrollment

Location

Arm

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the safety and efficacy of a Response Guided Therapy of boceprevir 800 mg dosed three times a day (TID) orally (PO) in combination with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected patients that failed to previous HCV therapy.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C HIV Infections COINFECTION	Drug: boceprevir Drug: Ribavirin Drug: Peginterferon alfa-2a Drug: Peginterferon alfa-2b	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Study to Evaluate Safety and Efficacy of Boceprevir-response Guided Therapy in Controlled HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin Eudra CT2012-003984-23

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: boceprevir + ribavirin + peginterferon boceprevir 800 mg three times a day (v.o.) in combination with peginterferon (alfa-2b or alfa-2a) and ribavirin	Drug: boceprevir Drug: Ribavirin Drug: Peginterferon alfa-2a Drug: Peginterferon alfa-2b

Arm

Intervention/Treatment

Experimental: boceprevir + ribavirin + peginterferon

boceprevir 800 mg three times a day (v.o.) in combination with peginterferon (alfa-2b or alfa-2a) and ribavirin

Drug: boceprevir

Drug: Ribavirin

Drug: Peginterferon alfa-2a

Drug: Peginterferon alfa-2b

Outcome Measures

Primary Outcome Measures

Achievement of sustained virological response (SVR) at week 24 [Week 24]
The primary efficacy endpoint is the achievement of SVR, defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If a subject is missing FW 24 data and has undetectable HCV-RNA level at FW 12, the subject would be considered an SVR.

Secondary Outcome Measures

Achievement of sustained virological response at weeks 2,4,8,12. [Weeks 2, 4, 8, 12]
The proportion of subjects with virological response (eg. undetectable HCV-RNA at Weeks 2, 4, 8, or 12) in subjects who achieve SVR.
The proportion of subjects with undetectable HCV-RNA at FW 12. [Week 12]
The proportion of subjects with undetectable HCV-RNA at FW 12.
The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization. [Week 72]
The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization.
Number of adverse events [From baseline to study completion (up to 72 weeks)]
Safety: number of adverse events
Resistance of HCV after boceprevir (BOC) containing regimen [whenever resistance occurs during the study (from week 12 until the date the resistance occurs, assessed up to 72 weeks)]
Resistance of HCV after boceprevir containing regimen. Blood samples will be collected at baseline and after HCV virological failure and resistance analysis will be done at the end of the study in a single Center (Hospital Clínic-Barcelona).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

For inclusion in the study, subjects must have a qualifying regimen defined as peginterferon alfa-2a plus ribavirin or peginterferon alfa-2b plus ribavirin for a minimum of 12 weeks. If a subject has received more than one such regimen, the most recent regimen is considered the qualifying regimen.
Subject must have previously documented chronic hepatitis C (CHC) genotype 1 infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result at the screening visit must confirm genotype 1 infection and be ≥10,000 IU/mL.
Subject must have a liver biopsy with histology consistent with CHC and no other etiology and/or Fibroscan assessment. In case of:

No cirrhosis. Biopsies and/or Fibroscan must be within 18 months of screening visit.
Cirrhosis. No specific length of time would be requested.

All patients with cirrhosis must have an ultrasound 6 month within of screening visit.
Patients must be on stable antiretroviral therapy including a CD4 cell count of more than 100 per mm3 and a HIV plasmatic viral load undetectable (it is < 50 copies/mL) for more than 6 months. Antiretroviral therapy must be Raltegravir-based (al least during the last 3 months).
Subject must be ≥18 years of age.
HIV treatment should not contain efavirenz (EFV), nevirapine (NVP), etravirine (ETV), didanosine (ddI), stavudine (d4T), zidovudine (AZT), or HIV protease inhibitors.
Subject must weight between 40 kg and 125 kg.
Subject and subject's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug.
Subjects must be willing to give written informed consent and by investigator opinion be able to follow the protocol visit design.

Exclusion Criteria:

Subjects known to be coinfected with hepatitis B virus (HBsAg positive).
Patients chronically infected with HCV genotype other than 1
CD4 cell count < 100 cel/mm3.
Plasma HIV RNA more than 50 copies/mL
Platelet count less than 80.000 /mm3
Subjects who required discontinuation of previous interferon or ribavirin regimen for a severe adverse event considered by the investigator to be possibly or probably related to ribavirin and/or interferon.
Treatment with ribavirin within 90 days and any interferon-alpha within 1 month of Screening.
Treatment for hepatitis C with any investigational medication. Prior treatments with herbal remedies with known hepatotoxicity are exclusionary.
Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.
History of hemoglobinopathy (e.g., thalassemia) or any other cause of or tendency to hemolysis.
Evidence of decompensate liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
Diabetic and/or hypertensive subjects with clinically significant ocular examination findings.
Unstable or untreated pre-existing psychiatric condition.
Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study.
Any current evidence of substance abuse of alcohol or other drugs.
Subjects receiving opioid agonist substitution therapy but not enrolled in an opiate substitution maintenance program.