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

• Status: Completed
• Trial end date: 1989-01-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Epoetin Alfa; Zidovudine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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