Status:
COMPLETED
Dutch Acute HCV in HIV Study (DAHHS)
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Onze Lieve Vrouwe Gasthuis
Conditions:
Hepatitis C
Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Stan...
Eligibility Criteria
Inclusion
- Documented recent HCV genotype 1 infection (≤26 weeks old at the time of the baseline visit) according to definition mentioned below.
- 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.
- A previously performed HCV RNA plasma measurement can be used for screening if \<4 weeks old.
- On HAART at the time of screening.
- Minimum age 18 years.
Exclusion
- 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.
- 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).
- 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.
- HAART was started \<4 weeks before baseline visit.
- 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.
- Patient that virologically failed HAART in the past
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01912495
Start Date
August 1 2013
End Date
January 1 2016
Last Update
April 1 2016
Active Locations (9)
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1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3000CA
2
AMC
Amsterdam, Netherlands
3
OLVG
Amsterdam, Netherlands
4
Slotervaart
Amsterdam, Netherlands