Overview
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
Terminated
Trial end date:
2006-09-01
2006-09-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
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