Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01912495
First received: July 29, 2013
Last updated: March 2, 2016
Last verified: March 2016
Results First Received: December 7, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatitis C
Human Immunodeficiency Virus
Intervention: Drug: Boceprevir

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Boceprevir 12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group

Participant Flow:   Overall Study
    Boceprevir
STARTED   57 [1] 
COMPLETED   57 
NOT COMPLETED   0 
[1] 8 patients had only screening visit, total enrollment: 65



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
Boceprevir/Peginterferon/Ribavirin Boceprevir with Peginterferon and Ribavirin

Baseline Measures
   Boceprevir/Peginterferon/Ribavirin 
Overall Participants Analyzed 
[Units: Participants]
 57 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 40 
 (34 to 47) 
Gender 
[Units: Participants]
 
Female   0 
Male   57 
Region of Enrollment 
[Units: Participants]
 
Netherlands   57 


  Outcome Measures
  Show All 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
  Hide 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
No text entered.


  More Information
  Hide 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
e-mail: b.rijnders@erasmusmc.nl


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

Responsible Party: Bart Rijnders, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01912495     History of Changes
Other Study ID Numbers: NL44825.078.13
Study First Received: July 29, 2013
Results First Received: December 7, 2015
Last Updated: March 2, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)