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

• Status: Completed
• Trial end date: 1989-08-01
• 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 [cells that are typical elements of lymph tissue] in the blood) as determined by a finding of <1,000 cells/cubic millimeter

• having a documented HIV antibody (either a history of infections due to the patient's impaired resistance or the presence of severe symptoms, such as persistent fever or night sweats associated with significant weight loss)

• receiving AZT therapy of at least 400 mg/day

• having a 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 at least 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 a sudden onset of infections, dementia due to AIDS, uncontrolled high blood pressure, or an iron deficiency

• received androgen therapy within 2 months of study entry

• having anemia caused by other conditions than AIDS or AZT therapy (for example, certain vitamin deficiencies or bleeding from the gastrointestinal tract)

• having a history of seizures, history of cell damage due to chemotherapy within 1 month before study entry, or a history of substance abuse.