Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100581
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2005-01-03
Brief Title:
Effects of Anti-HIV Therapy on Treatment for Hepatitis C in HCVHIV Infected Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open-Label Randomized Study to Determine the Impact of Antiretroviral Treatment in HCVHIV-Coinfected Subjects With High CD4 Cell Count on the Efficacy of Hepatitis C Treatment With Pegylated Interferon Alfa-2A and Ribavirin
Status:
COMPLETED
Status Verified Date:
2021-10
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:
A significant proportion of HIV infected people in the US are also infected with hepatitis C virus HCV The purpose of this study is to determine the effects of anti-HIV therapy on treatment of HCV with pegylated interferon alfa-2a and ribavirin PEGRBV
Detailed Description:
An estimated 15 to 30 of HIV infected people in the US are also infected with HCV Since the introduction of antiretroviral therapy ART for the treatment of HIV HCV infection has emerged as a major cause of morbidity and mortality in HCVHIV coinfected patients One infection often accelerates the progression of the other and effective management strategies for both infections need to be developed for HCVHIV coinfected patients This study will determine whether HIV ART followed by HCV therapy taken concurrently with ART results in better treatment outcomes compared to HCV therapy alone
This study will last up to 102 weeks Participants will be randomly assigned to one of two arms Arm A participants will receive 24 to 30 weeks of ART consisting of tenofovir disoproxil fumarate TDF and lamivudine 3TC and either efavirenz EFV or lopinavirritonavir LPVr If deemed eligible Arm A participants will continue their ART regimen and begin a concurrent PEGRBV regimen for up to 48 weeks At Week 48 participants in Arm A will stop PEGRBV and will be followed for an additional 24 weeks on ART alone
Arm B participants will receive PEGRBV alone for up to 48 weeks At Week 48 participants in Arm B will be followed for an additional 48 weeks with no treatment
There will be 20 study visits over 102 weeks for Arm A participants and 18 study visits over 96 weeks for Arm B participants Blood collection and clinical assessment will occur at all visits and urine collection will occur at selected visits Participants will also be asked to complete adherence questionnaires Participants in this study are encouraged to also enroll in ACTG A5128
This study will last up to 102 weeks Participants will be randomly assigned to one of two arms Arm A participants will receive 24 to 30 weeks of ART consisting of tenofovir disoproxil fumarate TDF and lamivudine 3TC and either efavirenz EFV or lopinavirritonavir LPVr If deemed eligible Arm A participants will continue their ART regimen and begin a concurrent PEGRBV regimen for up to 48 weeks At Week 48 participants in Arm A will stop PEGRBV and will be followed for an additional 24 weeks on ART alone
Arm B participants will receive PEGRBV alone for up to 48 weeks At Week 48 participants in Arm B will be followed for an additional 48 weeks with no treatment
There will be 20 study visits over 102 weeks for Arm A participants and 18 study visits over 96 weeks for Arm B participants Blood collection and clinical assessment will occur at all visits and urine collection will occur at selected visits Participants will also be asked to complete adherence questionnaires Participants in this study are encouraged to also enroll in ACTG A5128
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 |
|---|---|---|---|
| 10133 | REGISTRY | None | None |
| ACTG A5184 | Registry Identifier | DAIDS ES Registry Number | None |