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

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ClinicalTrials.gov Identifier: NCT00018031
Recruitment Status : Completed
First Posted : June 28, 2001
Results First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Shyamasundaran Kottilil, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C
HIV Infections
Interventions Drug: Peginterferon alfa-2b
Drug: Ribavirin
Enrollment 36

Recruitment Details 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 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.
Arm/Group Title Peginterferon Alfa-2b, Ribavirin
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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.

Period Title: Overall Study
Started 36
Completed 36
Not Completed 0
Arm/Group Title Peg-interefron Alfa 2b, Ribavirin
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
<=18 years
0
   0.0%
Between 18 and 65 years
34
  94.4%
>=65 years
2
   5.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
2
   5.6%
Male
34
  94.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
1.Primary Outcome
Title Participants With Viral Decline at Day 3 & 28 With Predictors of Post Treatment Response
Hide Description

HCV viral kinetics were used to predict rates of sustained virology response (SVR) in HIV/HCV connected subjects.

Measure was determined by analyzing the population of participants with virologic decline of more than 1.0 log at day 3 combined with viral load of less than 5.0 log IU/ml at day 28 to predict sustained virology response

Time Frame Day 3 and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with Virologic decline at both Day 3 and absolute HCV VL at Week 28 were analyzed
Arm/Group Title Peginterferon Alfa-2b, Ribavirin
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants with post treatment svr
8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Peg-interefron Alfa 2b, Ribavirin
Hide Arm/Group Description

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.

All-Cause Mortality
Peg-interefron Alfa 2b, Ribavirin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Peg-interefron Alfa 2b, Ribavirin
Affected / at Risk (%) # Events
Total   3/36 (8.33%)    
Eye disorders   
Vision Changes * [1]  1/36 (2.78%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Carcinoma * [2]  1/36 (2.78%)  1
Psychiatric disorders   
Unusual affect or behavior * [3]  1/36 (2.78%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required.
[2]
Mild to moderate limitation in activity; some assistance may be needed; no or minimal medical intervention required.
[3]
Marked limitation in activity; some assistance usually required; medical intervention/therapy required.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peg-interefron Alfa 2b, Ribavirin
Affected / at Risk (%) # Events
Total   20/36 (55.56%)    
General disorders   
Fatigue *  3/36 (8.33%)  4
Investigations   
Anemia * [1]  6/36 (16.67%)  7
Neutropenia * [2]  15/36 (41.67%)  43
*
Indicates events were collected by non-systematic assessment
[1]
Hemoglobin decreased
[2]
Neutrophil count decreased
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
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
First Submitted: June 27, 2001
First Posted: June 28, 2001
Results First Submitted: January 18, 2013
Results First Posted: October 1, 2014
Last Update Posted: October 1, 2014