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)
1 other identifier
interventional
292
0 countries
N/A
Brief Summary
The objective of this study was to treat anemic (Hemoglobin (Hb) \< 12 g/dL) HIV-infected subjects with once weekly (QW) PROCRIT (Epoetin alfa) to a target Hb of \> 13 g/dL and then to assess if the target Hb level and improvements in Quality of Life (QOL) could be maintained with every other week (Q2W) PROCRIT (Epoetin alfa) dosing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2002
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 21, 2006
CompletedFirst Posted
Study publicly available on registry
April 25, 2006
CompletedMay 19, 2011
April 1, 2010
April 21, 2006
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Understand and sign written informed consent
- HIV-infected patients (as documented by HIV-RNA values)
- HIV/HCV co-infected patients not receiving treatment
- Hemoglobin \< 12 g/dL unrelated to transfusion
- Estimated life expectancy of \> 9 months
- Has been maintained on a stable antiretroviral regimen for at least four weeks prior to enrollment into this study.
You may not qualify if:
- Acute, symptomatic opportunistic infection or other acute AIDS defining illness
- Anemia attributable to factors other than HIV infection (i.e., iron, B12 or folate deficiencies, hemolysis, gastrointestinal bleeding)
- HCV co-infected patients who are anticipated to receive treatment with ribavirin/interferon during the study period. Previous treatment with ribavirin/interferon must have been completed at least 12 weeks prior to study entry
- Ferritin level \< 40 ng/mL
- Uncontrolled or severe cardiovascular disease including recent (\< 6 months) myocardial infarction, uncontrolled hypertension or congestive heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Levine AM, Salvato P, Leitz GJ; Champs 2 Study Group. Efficacy of epoetin alfa administered every 2 weeks to maintain hemoglobin and quality of life in anemic HIV-infected patients. AIDS Res Hum Retroviruses. 2008 Feb;24(2):131-9. doi: 10.1089/aid.2006.0200.
PMID: 18284320DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ortho Biotech Products, L.P. Clinical Trial
Ortho Biotech Products, L.P.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 21, 2006
First Posted
April 25, 2006
Study Start
October 1, 2002
Study Completion
May 1, 2004
Last Updated
May 19, 2011
Record last verified: 2010-04