Dutch Acute HCV in HIV Study (DAHHS)

Hepatitis C Clinical Trial

— DAHHS  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01912495
• Other study ID #: NL44825.078.13
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 29, 2013
• Last updated: February 2, 2015
• Start date: August 2013
• Est. completion date: June 2015

Study information

• Verified date: February 2015
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hepatitis C
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Boceprevir

Locations

Country	Name	City	State
Netherlands	AMC	Amsterdam
Netherlands	OLVG	Amsterdam
Netherlands	Slotervaart	Amsterdam
Netherlands	Ziekenhuis Rijnstate	Arnhem
Netherlands	UMCG	Groningen
Netherlands	MUMC	Maastricht
Netherlands	Radboud UMCN	Nijmegen
Netherlands	Erasmus MC	Rotterdam	Zuid Holland
Netherlands	UMCU	Utrecht

Sponsors (9)

Lead Sponsor	Collaborator
Erasmus Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Maastricht University Medical Center, Onze Lieve Vrouwe Gasthuis, Radboud University, Rijnstate Hospital, Slotervaart Hospital, UMC Utrecht, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 weeks	No
Secondary	SVR 12 weeks after the end of all therapy in the entire study population (with or without RVR4).		12 weeks	No
Secondary	SVR 12 weeks after end of therapy in patients with already a RVR at week 1.		12 weeks	No
Secondary	SVR 12 weeks after end of therapy in patients that started therapy =12weeks after the presumed HCV infection date versus those after 12 weeks.		12 weeks	No
Secondary	Alterations of biomarkers by therapy induced viral eradication: Viral sequencing, mutation analysis, gene expression analysis, and RNA analysis.		72 weeks	No
Secondary	Safety: Treatment related (serious) adverse events ((S)AE) and treatment discontinuation for (S)AE.		72 weeks	Yes