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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01912495
Recruitment Status : Completed
First Posted : July 31, 2013
Results First Posted : April 1, 2016
Last Update Posted : April 1, 2016
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Boceprevir 12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group

Participant Flow:   Overall Study
STARTED   57 [1] 
[1] 8 patients had only screening visit, total enrollment: 65

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Boceprevir/Peginterferon/Ribavirin Boceprevir with Peginterferon and Ribavirin

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Inter-Quartile Range)
 (34 to 47) 
[Units: Participants]
Female   0 
Male   57 
Region of Enrollment 
[Units: Participants]
Netherlands   57 

  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4).   [ Time Frame: 12 weeks ]

3.  Secondary:   SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1.   [ Time Frame: 12 weeks ]

4.  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.   [ Time Frame: 12 weeks ]

5.  Secondary:   Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis.   [ Time Frame: 72 weeks ]

6.  Secondary:   Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE.   [ Time Frame: 72 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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

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

Responsible Party: Bart Rijnders, Erasmus Medical Center 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