Ignite Creation Date:
2024-05-06 @ 12:04 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01482767
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2011-11-28
Brief Title:
Evaluating the Effectiveness of Boceprevir Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus HCV Infection in Adults With HIV and HCV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Prospective Phase III Open-Label Study of Boceprevir Pegylated-Interferon Alfa 2b and Ribavirin in HCVHIV Coinfected Subjects
Status:
COMPLETED
Status Verified Date:
2016-06
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:
Hepatitis C virus HCV infection is a leading cause of death and illness in people with HIV-1 At the time the study was designed the standard treatment for people with HIV-1 and HCV coinfection included two drugs pegylated-interferon alfa 2b PEG-IFN and ribavirin RBV The purpose of this study was to evaluate the effectiveness of giving boceprevir BOC together with standard treatment in treating HCV infection in people with HIV-1 and HCV coinfection
Detailed Description:
For HIV-1-infected individuals HCV infection is a leading cause of morbidity and mortality and the prevalence of HCV infection is higher among those infected with HIV-1 At the time the study was designed the standard-of-care SOC therapy for HCV infection was treatment with both PEG-IFN and RBV This therapy is 40-45 effective in patients with HCV infection but is significantly less effective in patients with both HCV and HIV-1 Shire et al J Viral Hepat 2007 The purpose of this study was to evaluate the effectiveness of adding BOC Kwo et al Lancet 2010 an HCV protease inhibitor to SOC therapy in treating HCV infection genotype 1 in HCVHIV-1-coinfected adults
Participants were enrolled into one of two groups based on previous HCV treatment experience
1 Group A HCV treatment-naive participants who had never received treatment with PEG-IFN or experimental agents used to treat HCV with or without RBV N170 refer to the note below
2 Group B HCV treatment-experienced participants who had received any treatment with standard interferon or with PEG-IFN with or without RBV provided the last dose of treatment was 90 days or more before study entry N140 refer to the note below
Note The team correspondence with the FDA led to an amendment to close enrollment in December 2013 prior to the target sample sizes of 170 in Group A and 140 in Group B as the study power could be lowered while still meeting the key study objectives
All participants had to be on stable antiretroviral therapy ART for at least 8 weeks prior to study entry using a dual nucleostide reverse transcriptase inhibitor NRTI backbone plus one of the following efavirenz EFV raltegravir RAL lopinavir LPVritonavir RTV 400100 mg twice daily atazanavir ATVRTV darunavir DRVRTV 600100 mg twice daily OR must not have received any ART for at least 4 weeks immediately prior to entry Participation in this study lasted approximately 72 weeks
HCV treatment-naive participants Group A were treated with PEG-IFN and RBV for 4 weeks lead-in Then BOC was added to the treatment regimen triple therapy Cirrhotic participants received 44 weeks of triple therapy Among non-cirrhotics the Week 8 HCV RNA was used to determine total duration of therapy Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28 Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of double-drug therapy with PEG-IFNRBV HCV treatment-experienced participants Group B also had a lead-in followed by 32 weeks of triple therapy and 12 weeks of PEG-IFNRBV double therapy if non-cirrhotic or by 44 weeks of triple therapy if cirrhotic
Treatment was to be discontinued due to HCV virologic failure if
1 HCV RNA 100 IUmL at Week 12
2 detectable HCV RNA at Week 24 or
3 confirmed HCV RNA 1000 IUmL any time after Week 12
Undetectable HCV RNA was defined as below the lower limit of quantification LLOQ and target not detected TND by Roche COBAS TaqMan HCV Test v20
Study visits were scheduled at screening and at Weeks 2 4 6 8 10 12 16 20 24 and 28 for both study groups Group A participants who completed treatment at Week 28 had further study visits at Weeks 40 52 60 and 72 Participants who were prescribed 48-weeks of therapy Group A and Group B had further study visits at Weeks 32 36 40 44 48 60 and 72 At each visit a physical examination and blood collection were conducted Participants also completed an HCV treatment adherence questionnaire Select visits included urine collection and pregnancy testing for women of reproductive potential Plasma serum and peripheral blood mononuclear cells PBMCs were be stored for use in future studies After experiencing HCV virologic failure as defined above or premature treatment discontinuation due to safety or other reasons participants were followed on a separate schedule of events with visits every 12 weeks from Week 24 to 72 The evaluations at these follow-up visits were limited to safety evaluations and stored plasmaserum sample collection
The A5294 study consisted of single-arm evaluations to assess the efficacy of BOC added to PEG-IFNRBV in the two study populations
1 HCV treatment-naive participants Group A
2 HCV treatment-experienced participants Group B
The two study populations were addressed together in this single trial - rather than in two separate trials - mainly for administrative efficiency The analyses were conducted separately for each Study Group The study was not designed for comparison The pooled summaries for Baseline Characteristics provided in the Results Section in this record were prepared solely for the ClinicalTrialsgov results submission
Participants were enrolled into one of two groups based on previous HCV treatment experience
1 Group A HCV treatment-naive participants who had never received treatment with PEG-IFN or experimental agents used to treat HCV with or without RBV N170 refer to the note below
2 Group B HCV treatment-experienced participants who had received any treatment with standard interferon or with PEG-IFN with or without RBV provided the last dose of treatment was 90 days or more before study entry N140 refer to the note below
Note The team correspondence with the FDA led to an amendment to close enrollment in December 2013 prior to the target sample sizes of 170 in Group A and 140 in Group B as the study power could be lowered while still meeting the key study objectives
All participants had to be on stable antiretroviral therapy ART for at least 8 weeks prior to study entry using a dual nucleostide reverse transcriptase inhibitor NRTI backbone plus one of the following efavirenz EFV raltegravir RAL lopinavir LPVritonavir RTV 400100 mg twice daily atazanavir ATVRTV darunavir DRVRTV 600100 mg twice daily OR must not have received any ART for at least 4 weeks immediately prior to entry Participation in this study lasted approximately 72 weeks
HCV treatment-naive participants Group A were treated with PEG-IFN and RBV for 4 weeks lead-in Then BOC was added to the treatment regimen triple therapy Cirrhotic participants received 44 weeks of triple therapy Among non-cirrhotics the Week 8 HCV RNA was used to determine total duration of therapy Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28 Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of double-drug therapy with PEG-IFNRBV HCV treatment-experienced participants Group B also had a lead-in followed by 32 weeks of triple therapy and 12 weeks of PEG-IFNRBV double therapy if non-cirrhotic or by 44 weeks of triple therapy if cirrhotic
Treatment was to be discontinued due to HCV virologic failure if
1 HCV RNA 100 IUmL at Week 12
2 detectable HCV RNA at Week 24 or
3 confirmed HCV RNA 1000 IUmL any time after Week 12
Undetectable HCV RNA was defined as below the lower limit of quantification LLOQ and target not detected TND by Roche COBAS TaqMan HCV Test v20
Study visits were scheduled at screening and at Weeks 2 4 6 8 10 12 16 20 24 and 28 for both study groups Group A participants who completed treatment at Week 28 had further study visits at Weeks 40 52 60 and 72 Participants who were prescribed 48-weeks of therapy Group A and Group B had further study visits at Weeks 32 36 40 44 48 60 and 72 At each visit a physical examination and blood collection were conducted Participants also completed an HCV treatment adherence questionnaire Select visits included urine collection and pregnancy testing for women of reproductive potential Plasma serum and peripheral blood mononuclear cells PBMCs were be stored for use in future studies After experiencing HCV virologic failure as defined above or premature treatment discontinuation due to safety or other reasons participants were followed on a separate schedule of events with visits every 12 weeks from Week 24 to 72 The evaluations at these follow-up visits were limited to safety evaluations and stored plasmaserum sample collection
The A5294 study consisted of single-arm evaluations to assess the efficacy of BOC added to PEG-IFNRBV in the two study populations
1 HCV treatment-naive participants Group A
2 HCV treatment-experienced participants Group B
The two study populations were addressed together in this single trial - rather than in two separate trials - mainly for administrative efficiency The analyses were conducted separately for each Study Group The study was not designed for comparison The pooled summaries for Baseline Characteristics provided in the Results Section in this record were prepared solely for the ClinicalTrialsgov results submission
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 |
|---|---|---|---|
| 11774 | REGISTRY | None | None |
| ACTG 5294 | None | None | None |
| BIRTH | Registry Identifier | DAIDS ES | None |