A Study to Assess the Effectiveness of PROCRIT (Epoetin Alfa) Dosing Every 2 Weeks Versus Once a Week in Anemic HIV-infected Patients

• Status: Terminated
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Subjects must be documented HIV positive and on a stable antiretroviral regimen for at least four weeks prior to enrollment

• have a hemoglobin level <12.0 g/dL

• have not undergone cancer therapy (chemotherapy and/or radiation therapy) within 12 months prior to enrollment

Exclusion Criteria:

• History of acute, symptomatic opportunistic infection or other acute AIDS defining illness within six months of enrollment

• History of any primary hematologic disease

• Have anemia attributable to factors other than HIV infection (i.e. iron, or vitamin B12 deficiency, hemolysis, or gastrointestinal bleeding)

• Have Hepatitis C virus (HCV) co-infection

• Have uncontrolled or severe cardiovascular disease including recent myocardial infarction, hypertension, or congestive heart failure