Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246298
Status:
TERMINATED
Last Update Posted:
2011-06-10
First Post:
2005-10-28
Brief Title:
A Study to Assess the Effectiveness of PROCRIT Epoetin Alfa Dosing Every 2 Weeks Versus Once a Week in Anemic HIV-infected Patients
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Open-Label Study Assessing the Efficacy of Initiating PROCRIT Epoetin Alfa Dosing at Q2W vs PROCRIT Dosing at QW in Anemic HIV-infected Subjects
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
OBI business decision not to complete any additional research in HIV
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if PROCRITÂ a glycoprotein that stimulates red blood cell production initiated at once every 2 weeks dosing is as effective as PROCRITÂ initiated at once a week dosing in increasing hemoglobin levels in anemic HIV-infected subjects
Detailed Description:
In the Highly Active Antiretroviral Treatment HAART era anemia is one of the most common abnormalities in HIV-infected subjects Epoetin alfa is proven to increase hemoglobin levels and improve quality of life in HIV-infected subjects Although there are data to show that epoetin alfa dosed weekly significantly increases hemoglobin to a target level of 13 gdL and every other week dosing can maintain target hemoglobin there is no data to show that initiation of epoetin alfa every 2 weeks will increase hemoglobin levels significantly
This randomized two-arm open-label study will evaluate if initiating PROCRIT every other week dosing is as effective as initiating PROCRIT weekly dosing in increasing hemoglobin in anemic HIV-infected subjects The Screening phase will start 2 weeks prior to the first dose of PROCRIT HIV-infected subjects who have a hemoglobin level of 120 gdL and are on a stable antiretroviral regimen will be screened for study eligibility In the treatment phase subjects will be randomized in a 11 ratio to receive 40000 IU PROCRIT subcutaneous injections either weekly QW or every other week Q2W The primary endpoint is the change in hemoglobin from baseline to the end of study at Week 12 The safety and tolerability of PROCRIT in this subject population will be assessed by evaluating adverse events laboratory results and vital signs The total duration of this study is 14 weeks including a 2-week screening phase and a 12-week treatment phase The primary hypothesis is that the mean increase in hemoglobin for subjects receiving PROCRIT every 2 weeks is not lower than those receiving weekly PROCRIT dosing by more than 1 gdL Subjects will initially receive 40000 IU PROCRIT subcutaneous injections either weekly QW or every other week Q2W with subsequent dose adjustments if appropriate The maximum length of PROCRIT treatment for this study is 12 weeks
This randomized two-arm open-label study will evaluate if initiating PROCRIT every other week dosing is as effective as initiating PROCRIT weekly dosing in increasing hemoglobin in anemic HIV-infected subjects The Screening phase will start 2 weeks prior to the first dose of PROCRIT HIV-infected subjects who have a hemoglobin level of 120 gdL and are on a stable antiretroviral regimen will be screened for study eligibility In the treatment phase subjects will be randomized in a 11 ratio to receive 40000 IU PROCRIT subcutaneous injections either weekly QW or every other week Q2W The primary endpoint is the change in hemoglobin from baseline to the end of study at Week 12 The safety and tolerability of PROCRIT in this subject population will be assessed by evaluating adverse events laboratory results and vital signs The total duration of this study is 14 weeks including a 2-week screening phase and a 12-week treatment phase The primary hypothesis is that the mean increase in hemoglobin for subjects receiving PROCRIT every 2 weeks is not lower than those receiving weekly PROCRIT dosing by more than 1 gdL Subjects will initially receive 40000 IU PROCRIT subcutaneous injections either weekly QW or every other week Q2W with subsequent dose adjustments if appropriate The maximum length of PROCRIT treatment for this study is 12 weeks
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