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

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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:
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
Information provided by (Responsible Party):
Bart Rijnders, Erasmus Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C
Human Immunodeficiency Virus
Intervention Drug: Boceprevir
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Boceprevir
Hide Arm/Group Description 12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
Period Title: Overall Study
Started 57 [1]
Completed 57
Not Completed 0
[1]
8 patients had only screening visit, total enrollment: 65
Arm/Group Title Boceprevir/Peginterferon/Ribavirin
Hide Arm/Group Description Boceprevir with Peginterferon and Ribavirin
Overall Number of Baseline Participants 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 57 participants
40
(34 to 47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
Female
0
   0.0%
Male
57
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 57 participants
57
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
41 patients had a RVR4
Arm/Group Title Boceprevir, Peginterferon and Ribavirin
Hide Arm/Group Description:
12 week Boceprevir, Peginterferon and Ribavirin
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: participants
41
2.Secondary Outcome
Title SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4).
Hide Description The outcome is a number of all patients who started treatment having an undetectable HCV RNA 12 weeks after the end of therapy
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Total intention to treat population
Arm/Group Title Boceprevir, Peginterferon and Ribavirin
Hide Arm/Group Description:
12 week boceprevir, peginterferon and ribavirin in intention to treat group
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
49
3.Secondary Outcome
Title SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1.
Hide Description 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
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients having a rapid viral response at week 4 had a sustained viral response at 12(SVR12) weeks after treatment.
Arm/Group Title Boceprevir, Peginterferon and Ribavirin
Hide Arm/Group Description:
12 week Boceprevir, Peginterferon and Ribavirin
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
5
4.Secondary Outcome
Title SVR 12 Weeks After End of Therapy in Patients That Started Therapy ≤12weeks After the Presumed HCV Infection Date Versus Those After 12 Weeks.
Hide Description 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.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
5 patients were treated within 12 weeks after calculated transmission date. All other patients were treated between 12 and 26 weeks after calculated transmission date.
Arm/Group Title Boceprevir Peginterferon Ribavirin
Hide Arm/Group Description:
12 week Boceprevir peginterferon and ribavirin
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
5
5.Secondary Outcome
Title Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis.
Hide Description [Not Specified]
Time Frame 72 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
data were not collected during this study
Arm/Group Title Boceprevir Peginterferon Ribavirin
Hide Arm/Group Description:
Boceprevir peginterferon and ribavirin
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE.
Hide Description only serious adverse events are recorded in this secondary endpoint
Time Frame 72 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
57 patients started treatment and were at risk
Arm/Group Title Boceprevir, Peginterferon and Ribavirin
Hide Arm/Group Description:
12 week boceprevir, peginterferon and ribavirin in intention to treat group
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Boceprevir
Hide Arm/Group Description 12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
All-Cause Mortality
Boceprevir
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Boceprevir
Affected / at Risk (%)
Total   3/57 (5.26%) 
Cardiac disorders   
Myocardial infarction [1]  1/57 (1.75%) 
General disorders   
anemia [2]  1/57 (1.75%) 
Vascular disorders   
transient ischemic attack [3]  1/57 (1.75%) 
[1]
One myocardial infarction in a patient with a high-grade left anterior descending artery stenosis that was stented uneventfully (hemoglobin (Hb) 8∙7 mmol/L at the time of the infarction).
[2]
One anemia (Hb 5·1 mmol/L) for which a transfusion was given and the ribavirin dose was decreased.
[3]
One suspected transient ischemic attack that resolved spontaneously and with normal MRI findings (Hb 6∙6 mmol/L)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Boceprevir
Affected / at Risk (%)
Total   54/57 (94.74%) 
Blood and lymphatic system disorders   
Anemia [1]  47/57 (82.46%) 
anemia [2]  7/57 (12.28%) 
[1]
Grade 1 anemia was observed in 83%
[2]
grade 2 anemia was observed in 12%
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: B.J.A.Rijnders
Organization: Erasmus MC
Phone: 0031107034529
Responsible Party: Bart Rijnders, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01912495     History of Changes
Other Study ID Numbers: NL44825.078.13
First Submitted: July 29, 2013
First Posted: July 31, 2013
Results First Submitted: December 7, 2015
Results First Posted: April 1, 2016
Last Update Posted: April 1, 2016