Dutch Acute HCV in HIV Study (DAHHS) (DAHHS)

• ClinicalTrials.gov Identifier: NCT01912495
• Recruitment Status: Completed
• First Posted: July 31, 2013
• Results First Posted: April 1, 2016
• Last Update Posted: April 1, 2016
• Sponsor: Erasmus Medical Center
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Onze Lieve Vrouwe Gasthuis; UMC Utrecht; University Medical Center Groningen; Maastricht University Medical Center; Rijnstate Hospital; Slotervaart Hospital; Radboud University Medical Center
• Information provided by (Responsible Party): Bart Rijnders, Erasmus Medical Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Hepatitis C; Human Immunodeficiency Virus	Drug: Boceprevir	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Study Start Date: August 2013
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: January 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Boceprevir, peginterferon ribavirin; All patients were intended to be treated in the 12 week peginterferon, ribavirin and boceprevir arm.	Drug: Boceprevir; Other Name: Victrelis

Outcome Measures

Primary Outcome Measures :

1. Sustained Viral Response(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 ]
   The outcome is a number of the patients with an undetectable Hepatitis C Virus (HCV) RNA at week 4 that have an undetectable HCV RNA 12 weeks after end of treatment.

Secondary Outcome Measures :

1. SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4). [ Time Frame: 12 weeks ]
   The outcome is a number of all patients who started treatment having an undetectable HCV RNA 12 weeks after the end of therapy
2. SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1. [ Time Frame: 12 weeks ]
   The number of patients who were undetectable for HCV at week one that had an undetectable HCV RNA load 12 weeks after the end of treatment
3. 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 ]
   The number of patients having a undetectable HCV RNA 12 weeks after the end of treatment in the group patients that was treated within 12 week of calculated transmission date.
4. Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis. [ Time Frame: 72 weeks ]
5. Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE. [ Time Frame: 72 weeks ]
   only serious adverse events are recorded in this secondary endpoint

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Netherlands

Erasmus MC

Rotterdam, Zuid Holland, Netherlands, 3000CA

AMC

Amsterdam, Netherlands

OLVG

Amsterdam, Netherlands

Slotervaart

Amsterdam, Netherlands

Ziekenhuis Rijnstate

Arnhem, Netherlands

UMCG

Groningen, Netherlands

MUMC

Maastricht, Netherlands

Radboud UMCN

Nijmegen, Netherlands

UMCU

Utrecht, Netherlands

Sponsors and Collaborators

Erasmus Medical Center

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Onze Lieve Vrouwe Gasthuis

UMC Utrecht

University Medical Center Groningen

Maastricht University Medical Center

Rijnstate Hospital

Slotervaart Hospital

Radboud University Medical Center

Investigators

• Principal Investigator: Bart Rijnders, MD, PhD; Erasmus MC

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hullegie SJ, Claassen MA, van den Berk GE, van der Meer JT, Posthouwer D, Lauw FN, Leyten EM, Koopmans PP, Richter C, van Eeden A, Bierman WF, Newsum AM, Arends JE, Rijnders BJ. Boceprevir, peginterferon and ribavirin for acute hepatitis C in HIV infected patients. J Hepatol. 2016 Apr;64(4):807-12. doi: 10.1016/j.jhep.2015.12.004. Epub 2015 Dec 12.

• Responsible Party: Bart Rijnders, MD,PhD, Erasmus Medical Center
• ClinicalTrials.gov Identifier: NCT01912495
• Other Study ID Numbers: NL44825.078.13
• First Posted: July 31, 2013
• Results First Posted: April 1, 2016
• Last Update Posted: April 1, 2016
• Last Verified: March 2016

Additional relevant MeSH terms:

Hepatitis C; Acquired Immunodeficiency Syndrome; HIV Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases