Dutch Acute HCV in HIV Study (DAHHS)

NCT ID: NCT01912495

Last Updated: 2016-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-01-31

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.

Conditions

Hepatitis C; Human Immunodeficiency Virus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Boceprevir, peginterferon ribavirin

All patients were intended to be treated in the 12 week peginterferon, ribavirin and boceprevir arm.

Group Type: EXPERIMENTAL

Boceprevir

Intervention Type: DRUG

Interventions

Boceprevir

Intervention Type: DRUG

Other Intervention Names

Victrelis

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Onze Lieve Vrouwe Gasthuis

OTHER

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: collaborator

Rijnstate Hospital

OTHER

Sponsor Role: collaborator

Slotervaart Hospital

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bart Rijnders

MD,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bart Rijnders, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus MC

Rotterdam, South Holland, Netherlands

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

Countries

Netherlands

References

Popping S, Cuypers L, Claassen MAA, van den Berk GE, De Weggheleire A, Arends JE, Boerekamps A, Molenkamp R, Koopmans MPG, Verbon A, Boucher CAB, Rijnders B, van de Vijver DAMC. Persistent Transmission of HCV among Men Who Have Sex with Men despite Widespread Screening and Treatment with Direct-Acting Antivirals. Viruses. 2022 Sep 2;14(9):1953. doi: 10.3390/v14091953.

Reference Type: DERIVED

PMID: 36146760 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26689767 (View on PubMed)

Other Identifiers

NL44825.078.13

Identifier Type: -

Identifier Source: org_study_id