Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 36 of 396 for:    IFNA2 AND RBV AND sustained

Peginterferon Alpha-2a and Ribavirin to Treat Hepatitis C in HIV-infected Patients (PIFNPK)

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.
 
ClinicalTrials.gov Identifier: NCT00085917
Recruitment Status : Completed
First Posted : June 17, 2004
Results First Posted : June 15, 2011
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C
HIV Infections
Interventions Drug: Double dose pegylated interferon with weight based Ribavirin
Drug: standard dose pegylated interferon alfa -2a and ribavirin
Enrollment 29
Recruitment Details Recruitment period was over a period of 3 yrs from 2004 - 2007. Participants were recruited and screened through the OP8 clinic of the NIAID.
Pre-assignment Details

There were no significant events or approaches following participant enrollment prior to group assignments.

However if enrolled participants subsequently developed exclusion criteria such as active alcohol or drug abuse, they were excluded from the study.

Arm/Group Title Pegasys Single Dose Pegasys Double Dose
Hide Arm/Group Description

pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)

- Treatment for 48 weeks

pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks

- Total Treatment for 48 weeks

Period Title: Overall Study
Started 15 14
Completed 11 11
Not Completed 4 3
Reason Not Completed
Adverse Event             4             3
Arm/Group Title Pegasys Single Dose Pegasys Double Dose Total
Hide Arm/Group Description

pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)

- Treatment for 48 weeks

pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks

- Total Treatment for 48 weeks

Total of all reporting groups
Overall Number of Baseline Participants 15 14 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
14
 100.0%
29
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 14 participants 29 participants
48  (6.402) 46  (5.93) 47  (6.109)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 29 participants
Female
4
  26.7%
4
  28.6%
8
  27.6%
Male
11
  73.3%
10
  71.4%
21
  72.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 14 participants 29 participants
15 14 29
1.Primary Outcome
Title Number of Participants With Sustained Virologic Response (SVR)
Hide Description SVR [ Sustained virological response] SVR was defined as HCV RNA levels below the limit of detection 24 weeks after the end of treatment.
Time Frame 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pegasys Single Dose Pegasys Double Dose
Hide Arm/Group Description:

pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)

- Treatment for 48 weeks

pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks

- Total Treatment for 48 weeks

Overall Number of Participants Analyzed 11 11
Measure Type: Number
Unit of Measure: participants
11 11
2.Secondary Outcome
Title Number of Participants With Normalization of Liver Enzymes
Hide Description normalization of liver enzymes :Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) Alanine aminotransferase (ALT): Normal 6 - 41 U/L Aspartate aminotransferase (AST) : Normal 9 - 34 U/L
Time Frame week 24, week 48, week 72
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pegasys Single Dose Pegasys Double Dose
Hide Arm/Group Description:

pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)

- Treatment for 48 weeks

pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks

- Total Treatment for 48 weeks

Overall Number of Participants Analyzed 11 11
Measure Type: Number
Unit of Measure: participants
11 11
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

Adverse Events

- Anemia, Neutropenia and Psychiatric adverse events

Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pegasys Single Dose Pegasys Double Dose
Hide Arm/Group Description:

pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)

- Treatment for 48 weeks

pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks

- Total Treatment for 48 weeks

Overall Number of Participants Analyzed 11 11
Measure Type: Number
Unit of Measure: participants
11 11
Time Frame 2 YEARS
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pegasys Single Dose Pegasys Double Dose
Hide Arm/Group Description

pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)

- Treatment for 48 weeks

pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks

- Total Treatment for 48 weeks

All-Cause Mortality
Pegasys Single Dose Pegasys Double Dose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pegasys Single Dose Pegasys Double Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/11 (36.36%)      7/11 (63.64%)    
Blood and lymphatic system disorders     
Neutropenia *  2/11 (18.18%)  2 6/11 (54.55%)  6
Anemia *  1/11 (9.09%)  1 1/11 (9.09%)  1
Psychiatric disorders     
Depression *  1/11 (9.09%)  1 1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pegasys Single Dose Pegasys Double Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/11 (81.82%)      9/11 (81.82%)    
Blood and lymphatic system disorders     
Anemia *  6/11 (54.55%)  6 7/11 (63.64%)  7
Neutropenia *  9/11 (81.82%)  9 8/11 (72.73%)  9
Thrombocytopenia *  4/11 (36.36%)  4 4/11 (36.36%)  4
General disorders     
Fatigue *  2/11 (18.18%)  2 3/11 (27.27%)  3
Weight loss *  2/11 (18.18%)  2 3/11 (27.27%)  3
Hepatobiliary disorders     
Elevated transaminases *  8/11 (72.73%)  8 6/11 (54.55%)  6
Psychiatric disorders     
Depression/anxiety *  6/11 (54.55%)  6 6/11 (54.55%)  6
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Tierney
Organization: RCHSPB
Phone: 301-451-5136
EMail: john.tierney@nih.gov
Layout table for additonal information
Responsible Party: Shyamasundaran Kottilil, M.D./National Institute of Allergy and Infectious Diseases, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00085917     History of Changes
Other Study ID Numbers: 040187
04-I-0187
First Submitted: June 16, 2004
First Posted: June 17, 2004
Results First Submitted: April 12, 2010
Results First Posted: June 15, 2011
Last Update Posted: June 27, 2011