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)

Phase 4 Completed 292 enrolled Ortho Biotech Products, L.P.

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2002-10
Primary completion: —
Completion: 2004-05

Outcome

Met primary endpoint

paper QOL was maintained from the beginning (GHP = 44.2 points) to the end of MP (GHP = 43.4 points) PMID 18284320 ↗

paper the results confirm the efficacy of prolonged dosing intervals (every 2-4 weeks) in maintaining optimal Hb levels and QOL PMID 18284320 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	epoetin alfa	Protein / enzyme biologic	40000 iu	Subcutaneous
Subject	epoetin alfa	Protein / enzyme biologic	60000 iu	Subcutaneous