Peginterferon Alpha-2a and Ribavirin to Treat Hepatitis C in HIV-infected Patients (PIFNPK)
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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: 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 |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 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
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
|
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. |
Reporting Groups
| Description | |
|---|---|
| Pegasys Single Dose |
pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) - Treatment for 48 weeks |
| Pegasys Double Dose |
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 |
Participant Flow: Overall Study
| Pegasys Single Dose | Pegasys Double Dose | |
|---|---|---|
| STARTED | 15 | 14 |
| COMPLETED | 11 | 11 |
| NOT COMPLETED | 4 | 3 |
| Adverse Event | 4 | 3 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Pegasys Single Dose |
pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) - Treatment for 48 weeks |
| Pegasys Double Dose |
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 | Total of all reporting groups |
Baseline Measures
| Pegasys Single Dose | Pegasys Double Dose | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
15 | 14 | 29 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 14 | 29 |
| >=65 years | 0 | 0 | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
48 ± 6.402 | 46 ± 5.93 | 47 ± 6.109 |
|
Gender
[units: participants] |
|||
| Female | 4 | 4 | 8 |
| Male | 11 | 10 | 21 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 15 | 14 | 29 |
Outcome Measures
| 1. Primary: | Number of Participants With Sustained Virologic Response (SVR) [ Time Frame: 72 weeks ] |
| 2. Secondary: | Number of Participants With Normalization of Liver Enzymes [ Time Frame: week 24, week 48, week 72 ] |
Hide Outcome Measure 2| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Participants With Normalization of Liver Enzymes |
| Measure 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 |
| Safety Issue | No |
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 | |
|---|---|
| Pegasys Single Dose |
pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) - Treatment for 48 weeks |
| Pegasys Double Dose |
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 |
Measured Values
| Pegasys Single Dose | Pegasys Double Dose | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
11 | 11 |
|
Number of Participants With Normalization of Liver Enzymes
[units: participants] |
11 | 11 |
No statistical analysis provided for Number of Participants With Normalization of Liver Enzymes
| 3. Secondary: | Number of Participants With Adverse Events [ Time Frame: 48 weeks ] |
More Information
| All Principal Investigators ARE employed by the organization sponsoring the study. |
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 |
|---|
| Small number of enrolled participants |
Results Point of Contact:
Publications:
| 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 |
| Study First Received: | June 16, 2004 |
| Results First Received: | April 12, 2010 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Federal Government |