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

NCT00246298 | Terminated Phase 2

• 1 other identifier: CR003220
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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 a week dosing, in increasing hemoglobin levels in anemic HIV-infected subjects.

Conditions

Anemia; HIV

Keywords

Anemia; erythropoetin; Epoetin alfa; erythropoietin recombinant; HIV infection; HIV; AIDS

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin from baseline to the end of study at Week 12

Secondary Outcomes (1)

• Safety and tolerability of every other week dosing and once a week dosing.

Interventions

epoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Ortho Biotech Products, L.P.: collaborator

Related Links

• A Randomized, Open Label Study Assessing the Efficacy of Initiating PROCRIT Dosing at Q2W vs. PROCRIT Dosing at QW in Anemic HIV-infected Patients

MeSH Terms

Conditions

Anemia; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: October 31, 2005
• Study Start: October 1, 2005
• Study Completion: September 1, 2006
• Last Updated: June 10, 2011

Record last verified: 2010-03