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Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients (HEPCPR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shyamasundaran Kottilil, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00018031
First received: June 27, 2001
Last updated: September 25, 2014
Last verified: September 2014
Results First Received: January 18, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatitis C
HIV Infections
Interventions: Drug: Peginterferon alfa-2b
Drug: Ribavirin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were all recruited from other NIAID HIV clinical trials and from the nearby Maryland, Virginia and the District of Columbia HIV clinics

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Open label study. The participants were only excluded if they did not meet eligibility criteria, such as pregnancy, availability to make frequent clinic visits and able to meet laboratory safety criteria as described in the clinical protocol.

Reporting Groups
  Description
Peginterferon Alfa-2b, Ribavirin

Weekly Injection (Peginterferon alfa-2b)

Peginterferon Alfa-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously

Oral Pills (Ribavirin)

Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks.


Participant Flow:   Overall Study
    Peginterferon Alfa-2b, Ribavirin  
STARTED     36  
COMPLETED     36  
NOT COMPLETED     0  



  Baseline Characteristics
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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
Peg-interefron Alfa 2b, Ribavirin

Weekly Injection

Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously

Oral Pills

Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks.


Baseline Measures
    Peg-interefron Alfa 2b, Ribavirin  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     34  
>=65 years     2  
Gender  
[units: participants]
 
Female     2  
Male     34  
Region of Enrollment  
[units: participants]
 
United States     36  



  Outcome Measures

1.  Primary:   Participants With Viral Decline at Day 3 & 28 With Predictors of Post Treatment Response   [ Time Frame: Day 3 and Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Shyam Kottilil
Organization: NIAID/NIH
phone: 301-435-036
e-mail: skottilil@niaid.nih.gov


Publications of Results:


Responsible Party: Shyamasundaran Kottilil, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00018031     History of Changes
Other Study ID Numbers: 010194, 01-I-0194
Study First Received: June 27, 2001
Results First Received: January 18, 2013
Last Updated: September 25, 2014
Health Authority: United States: Federal Government