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

NCT01718301 | Terminated Phase 3 Results

• 2 other identifiers: BOC-HIV2012-003984-23
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; HIV Infections; COINFECTION

Keywords

HCV; HIV; Coinfection

Outcome Measures

Primary Outcomes (1)

• Achievement of Sustained Virological Response (SVR) at 24 Weeks Post-Treatment

  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.

  Week 24

Secondary Outcomes (5)

• Achievement of Sustained Virological Response at Weeks 2,4,8,12.

  Weeks 2, 4, 8, 12

• The Proportion of Subjects With Undetectable HCV-RNA at FW 12.

  Week 12

• The Proportion of Subjects With Undetectable HCV-RNA at 72 Weeks After Randomization.

  Week 72

• Number of Adverse Events

  From baseline to study completion (up to 72 weeks)

• 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)

Study Arms (1)

boceprevir + ribavirin + peginterferon

EXPERIMENTAL

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

Interventions

boceprevir DRUG

boceprevir + ribavirin + peginterferon

Ribavirin DRUG

boceprevir + ribavirin + peginterferon

Peginterferon alfa-2a DRUG

boceprevir + ribavirin + peginterferon

Peginterferon alfa-2b DRUG

boceprevir + ribavirin + peginterferon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Anna Cruceta: lead

Study Sites (1)

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Hepatitis C; HIV Infections; Coinfection

Interventions

N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; Ribavirin; peginterferon alfa-2a; peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr Josep Mallolas Masferrer
• Organization: Infetious disesases

jmallolas@clinic.ub.es

932275400

Study Officials

• Josep Mallolas, MD

  Hospital Clínic i Provincial de Barcelona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research manager

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 31, 2012
• Study Start: March 10, 2013
• Primary Completion: March 20, 2015
• Study Completion: June 30, 2015
• Last Updated: August 24, 2025
• Results First Posted: August 24, 2025

Record last verified: 2025-08

Locations

ES (1)