HIV Clinical Trial
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
The purpose of this study is to determine if PROCRIT® (a glycoprotein that stimulates red blood cell production) initiated at once every 2 weeks dosing is as effective as PROCRIT® initiated at once a week dosing, in increasing hemoglobin levels in anemic HIV-infected subjects.
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 g/dL
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 <12.0 g/dL and are on
a stable antiretroviral regimen will be screened for study eligibility. In the treatment
phase, subjects will be randomized in a 1:1 ratio to receive 40,000 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 g/dL. Subjects will initially receive
40,000 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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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