Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Epoetin Alfa Versus Placebo for the Treatment of Anemia in Patients With Acquired Immunodeficiency Syndrome (AIDS) Who Are Receiving Zidovudine (AZT) Therapy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Acquired Immunodeficiency Syndrome
Anemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa in AIDS patients for the treatment of anemia that is a result of the disease and zidovudine (AZT) treatment. Epoet...
Detailed Description
It is estimated that approximately 75% to 80% of patients with AIDS experience anemia, which can be caused by AIDS or by the therapy patients receive for AIDS treatment (for example, zidovudine \[AZT\...
Eligibility Criteria
Inclusion
- Patients with a confirmed diagnosis of AIDS - having a Performance score of 0, 1, or 2 (patients' ability to perform daily activities, a score ranging from 0 \[fully active, no disease restriction\] to 3 \[capable of only limited self-care, confined to bed or chair more than 50% of waking hours\]) - taking a maintenance dose of AZT of at least 400 mg/day - having a hematocrit of at least 30% and a history of a \>=15% decrease in hematocrit since starting AZT therapy, or have become dependent on transfusions - who are clinically stable for at least 1 month before study entry.
Exclusion
- Patients having a history of any important blood disease - having any clinically significant disease or malfunction of the lungs, heart, hormones, neurological, gastrointestinal, reproductive or urinary systems, which is not caused by the AIDS infection - having dementia due to AIDS, a history of seizures, uncontrolled high blood pressure, or an iron deficiency - 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 sudden onset of infections, or a history of cell damage due to chemotherapy within 1 month before study entry.
Key Trial Info
Start Date :
July 1 1988
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 1990
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00270283
Start Date
July 1 1988
End Date
April 1 1990
Last Update
May 18 2011
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