Status:
TERMINATED
A Study to Assess the Effectiveness of PROCRIT (Epoetin Alfa) Dosing Every 2 Weeks Versus Once a Week in Anemic HIV-infected Patients
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Products, L.P.
Conditions:
Anemia
HIV
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
In the Highly Active Antiretroviral Treatment (HAART) era, anemia is one of the most common abnormalities in HIV-infected subjects. Epoetin alfa is proven to increase hemoglobin levels and improve qua...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00246298
Start Date
October 1 2005
End Date
September 1 2006
Last Update
June 10 2011
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