An Open-Label Study to Evaluate the Effect of Every Other Week PROCRIT� (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients (CHAMPS II)
|ClinicalTrials.gov Identifier: NCT00317902|
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : May 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Anemia HIV Infections||Drug: Epoetin alfa||Phase 4|
This was a Phase IV, open-label, non-randomized, multi-center study conducted in community based practices, physicians networks, or academic institutions in the US. This study included anemic (Hb < 12 g/dL) HIV-infected subjects and HIV/hepatitis C (HCV) co-infected subjects not receiving HCV treatment on a stable anti-retroviral therapy (ART) regimen for at least 4 weeks prior to enrollment.
Quality of life assessments, laboratory results, and transfusion information were obtained during the study. Laboratory tests, vital signs (blood pressure), and incidence and severity of adverse events were collected and assessed.
The primary objective of this study was to assess if every other week PROCRIT (Epoetin alfa) dosing can maintain quality of life in anemic HIV-infected patients. The primary hypothesis of interest was that the mean quality of life score (as measured by MOS-HIV General Health Perception score) at the end of the every other week (Q2W) maintenance phase was not lower than that at the beginning of the maintenance phase by more than 7 points.
It was anticipated that less frequent dosing, every other week, was more convenient for patients and will improve patient compliance. The starting dose (Baseline/Study Day 1) of PROCRIT (Epoetin alfa) for all eligible subjects was 40,000 U given subcutaneously QW. The maximum duration was 24 weeks. Subjects who achieved target Hb levels >= 13 g/dL were converted to a maintenance dose of PROCRIT (Epoetin alfa) sc Q2W.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||292 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study to Evaluate The Effect of Every Other Week PROCRIT (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients|
|Study Start Date :||October 2002|
|Actual Study Completion Date :||May 2004|
- The primary objective of this study was to assess if every other week PROCRIT (Epoetin alfa) dosing can maintain quality of life (QOL) in anemic HIV-infected patients between Week 24 (or the last measurement) and the beginning of the maintenance phase
- The effect of every other week PROCRIT (Epoetin alfa) dosing on maintaining target hemoglobin levels (>13 g/dL), transfusion utilization and safety in anemic HIV-infected patients measured from the beginning of the maintenance phase to Week 24.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317902
|Study Director:||Ortho Biotech Products, L.P. Clinical Trial||Ortho Biotech Products, L.P.|