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)

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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