Overview

This trial is active, not recruiting.

Conditions hepatitis c, human immunodeficiency virus
Treatment boceprevir
Phase phase 2
Sponsor Erasmus Medical Center
Collaborator Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Start date August 2013
End date March 2015
Trial size 60 participants
Trial identifier NCT01912495, NL44825.078.13

Summary

Prospective open label proof of concept feasibility interventional clinical trial in which 60 acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds at week 4.

The primary hypothesis of this study is that the subset of patients with a Rapid Viral Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
boceprevir Victrelis

Primary Outcomes

Measure
Sustained Viral Responds(SVR) 12 weeks of follow up after the end of all therapy for the Rapid Viral Response at week 4(RVR4) population.
time frame: 12 weeks

Secondary Outcomes

Measure
SVR 12 weeks after the end of all therapy in the entire study population (with or without RVR4).
time frame: 12 weeks
SVR 12 weeks after end of therapy in patients with already a RVR at week 1.
time frame: 12 weeks
SVR 12 weeks after end of therapy in patients that started therapy ≤12weeks after the presumed HCV infection date versus those after 12 weeks.
time frame: 12 weeks
Alterations of biomarkers by therapy induced viral eradication: Viral sequencing, mutation analysis, gene expression analysis, and RNA analysis.
time frame: 72 weeks
Safety: Treatment related (serious) adverse events ((S)AE) and treatment discontinuation for (S)AE.
time frame: 72 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Documented recent HCV genotype 1 infection (≤26 weeks old at the time of the baseline visit) according to definition mentioned below. 2. Plan to start a Standard Of Care therapy for acute HCV consisting of 24 weeks of Peginterferon + Ribavirin. HCV RNA plasma viral load at screening >1000 IU/ml. 3. A previously performed HCV RNA plasma measurement can be used for screening if <4 weeks old. 4. On HAART at the time of screening. 5. Minimum age 18 years. Exclusion Criteria: 1. Disallowed co-medication that cannot be stopped or replaced: Several potentially life-threatening drug-drug interactions (DDI) are possible when boceprevir is combined with other drugs. Therefore ALL co-medication, including over-the-counter drugs should be checked for potential DDI with DDI table in the Dutch summary of product characteristics (SPC, appendix A). If the co-medication is not mentioned in the SPC DDI table, www.HCV-druginteractions.org should be used. 2. Contraindications for the use of full dose of peginterferon alpha-2b or ribavirin: neutrophils <0,75×109/l or thrombocytes < 100.000×109/l or a Hb <6.2mmol/L, creatinine clearance <50ml/min). 3. History of liver cirrhosis or >F1 fibrosis on fibroscan. Inclusion of patients with a chronic well-controlled HBV (HBV-DNA below the limit of detection) with tenofovir, lamivudine or emtricitabine therapy is allowed if fibroscan excludes >F1 fibrosis. Fibroscan reports <2 years old can be used for screening. Fibroscan is not required for other patients at screening. 4. HAART was started <4 weeks before baseline visit. 5. Inability to switch to a HAART regimen consisting of 2 nucleoside/tide reverse transcriptase inhibitors + Raltegravir (Isentress®) 400mg BID or rilpivirine 25mg QD or atazanavir (Reyataz®) 300mg QD + ritonavir (Norvir®) 100mg QD. 6. Patient that virologically failed HAART in the past

Additional Information

Official title Efficacy of 12 Week Boceprevir in Addition to Standard of Care Therapy Consisting of Peginterferon-alpha-2b and Ribavirin for the Treatment of Acute HCV Genotype 1 in HIV Co-infected Patients. A Proof of Concept Feasibility Clinical Trial.
Principal investigator Bart Rijnders, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Erasmus Medical Center.