Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078403
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2004-02-24
Brief Title:
Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus HCV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Suppressive Long-Term Antiviral Management of Hepatitis C Virus HCV and HIV-1 Coinfected Subjects SLAM-C
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Infection with both HIV and hepatitis C virus HCV may result in serious and sometimes fatal liver disease The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a PEG-IFN and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV
Detailed Description:
Rapid progression of liver disease to liver failure has been observed in people coinfected with HIV and HCV This observation appears to be directly related to an increase in the rate of fibrotic progression in the liver compared to people infected with HCV alone PEG-IFN and ribavirin are used in standard treatment of HCV This study tested the effectiveness of using PEG-IFN in reducing the rate of liver fibrosis progression in participants coinfected with HIV and HCV who could not lower their HCV viral load to undetectable or who could not maintain their HCV viral load at undetectable on PEG-IFN and ribavirin treatment
Participants entered Step 1 initial run-in period to receive 12 weeks of 180 mcg PEG-IFN subcutaneously once weekly plus 1 to 12 gday ribavirin based on body weight At week 12 HCV RNA testing was performed
Participants with early virologic response EVR defined as 2 log10 drop in HCV RNA from baseline or undetectable HCV RNA 600 IUml with quantitative assay used in Step 1 at Week 12 who had tolerated Step 1 treatment entered into Step 3 to continue receiving the Step 1 treatment for a total of 72 weeks Arm C Participants who did not meet the criteria for entry into Step 3 were discontinued from the study In Step 3 participants were followed for an additional 24 weeks after treatment discontinuation to determine sustained virologic response SVR Initially Step 3 participants who had a detectable HCV viral load 60 IUml with the qualitative assay used in Step 3 at Week 36 were eligible to enroll in Step 2 After early closure of Step 2 such participants remained in Step 3 until study completion
Participants with 2 log10 drop in HCV RNA from baseline and detectable HCV RNA at Week 12 non-EVR discontinued Step 1 treatment Non-EVRs who met the Step 2 eligibility criteria were enrolled in Step 2 and randomized to receive 180 mcg PEG-IFN subcutaneously weekly for 72 weeks Arm A or observation for 72 weeks Arm B Participants who did not meet the criteria for entry into Step 2 were discontinued from the study Step 2 of the study was closed prematurely in May 2007 due to lower than expected progression rates among the participants in the observation arm such that the primary objective could not be reached There were no safety concerns
Liver biopsies were conducted at study screening and at Step 2 entry and exit until the early closure of Step 2 Medical history assessment physical exams and blood collection were conducted every 4-12 weeks for participants in Steps 1 2 and 3 Participants were followed for up to 18 weeks in Step 1 followed by a total of 72 in Step 2 or by up to a total of 84 weeks in Step 3
Participants entered Step 1 initial run-in period to receive 12 weeks of 180 mcg PEG-IFN subcutaneously once weekly plus 1 to 12 gday ribavirin based on body weight At week 12 HCV RNA testing was performed
Participants with early virologic response EVR defined as 2 log10 drop in HCV RNA from baseline or undetectable HCV RNA 600 IUml with quantitative assay used in Step 1 at Week 12 who had tolerated Step 1 treatment entered into Step 3 to continue receiving the Step 1 treatment for a total of 72 weeks Arm C Participants who did not meet the criteria for entry into Step 3 were discontinued from the study In Step 3 participants were followed for an additional 24 weeks after treatment discontinuation to determine sustained virologic response SVR Initially Step 3 participants who had a detectable HCV viral load 60 IUml with the qualitative assay used in Step 3 at Week 36 were eligible to enroll in Step 2 After early closure of Step 2 such participants remained in Step 3 until study completion
Participants with 2 log10 drop in HCV RNA from baseline and detectable HCV RNA at Week 12 non-EVR discontinued Step 1 treatment Non-EVRs who met the Step 2 eligibility criteria were enrolled in Step 2 and randomized to receive 180 mcg PEG-IFN subcutaneously weekly for 72 weeks Arm A or observation for 72 weeks Arm B Participants who did not meet the criteria for entry into Step 2 were discontinued from the study Step 2 of the study was closed prematurely in May 2007 due to lower than expected progression rates among the participants in the observation arm such that the primary objective could not be reached There were no safety concerns
Liver biopsies were conducted at study screening and at Step 2 entry and exit until the early closure of Step 2 Medical history assessment physical exams and blood collection were conducted every 4-12 weeks for participants in Steps 1 2 and 3 Participants were followed for up to 18 weeks in Step 1 followed by a total of 72 in Step 2 or by up to a total of 84 weeks in Step 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10008 | REGISTRY | DAIDS ES Registry Number | None |