A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa in AIDS Patients With Anemia Caused Both by Their Disease and by AZT (Zidovudine, an Antiviral Drug) Given as Treatment for Their Disease

NCT00269945 | Completed Phase 2

• 1 other identifier: CR005836
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus placebo for the treatment of anemia in AIDS (Acquired Immunodeficiency Syndrome) patients with anemia that is a result of this disease and zidovudine (AZT) treatment. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Conditions

Anemia; Acquired Immunodeficiency Syndrome

Keywords

Anemia; AIDS; HIV; Zidovudine; Quality of Life; erythropoietin; epoetin alfa

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin, hematocrit, and reticulocytes (laboratory tests used to evaluate the severity of anemia), transfusion requirements, and patient's quality of life assessment.

Secondary Outcomes (1)

• Adverse events; changes in clinical laboratory tests, vital sign measurements, ECGs, and physical examination findings; and physician's global evaluation of the overall effect of the drug

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:

• Patients with a confirmed diagnosis of AIDS, exhibiting signs and symptoms of AIDS characterized by lymphocytopenia (decrease in the number of lymphocytes in the blood) as determined by a finding of \<1,000 cells/cubic millimeter and a documented (if available) decrease in CD4 (a protein found on certain cells that has an affinity for the HIV virus) positive lymphocytes as determined by a finding of \<400 cells/cubic millimeter
• presence of HIV antibody
• documented history of infection (such as pneumonia) resulting from the patient's impaired resistance
• hematocrit \<=30%, and a history of a \>=15% decrease in hematocrit since starting AZT therapy, or that the patient has become dependent on transfusions
• clinically stable for \>=1 month before study entry, with a performance score of 0, 1, or 2.

You may not qualify if:

• Patients with a history of any important blood disease, or clinically significant disease or malfunction of the lungs, heart, hormones, neurological, gastrointestinal, reproductive or urinary systems, which are not caused by the AIDS infection
• having anemia caused by other conditions than AIDS or AZT therapy (for example, certain vitamin deficiencies or bleeding from the gastrointestinal tract)
• having a sudden onset of infections, dementia due to AIDS, uncontrolled high blood pressure, or an iron deficiency
• having a history of seizures, history of cell damage due to chemotherapy within 1 month before study entry, or a history of substance abuse
• received androgen therapy within 2 months before study entry

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• A study to evaluate the safety and effectiveness of epoetin alfa in AIDS (acquired immunodeficiency syndrome) patients with anemia caused both by their disease and by AZT (zidovudine, an antiviral drug) given as treatment for their disease

MeSH Terms

Conditions

Anemia; Acquired Immunodeficiency Syndrome

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System 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: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Completion: January 1, 1989
• Last Updated: May 18, 2011

Record last verified: 2010-04