Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Epoetin Alfa Versus Placebo for the Treatment of Anemia in AIDS (Acquired Immunodeficiency Syndrome) Patients With Anemia Caused by the Disease and by 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 versus placebo in AIDS patients for the treatment of anemia that is a result of the disease or a result of zidovud...
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, with a hematocrit \<=30% - preferably dependent on transfusions - having a history of at least a 15% decrease in hematocrit since the beginning of AZT therapy, or have become dependent on transfusions - who are clinically stable for at least 1 month before study entry - females must be at least 1 year post-menopausal, surgically sterile, or practicing an effective method of birth control, and have a negative pregnancy test before study entry.
Exclusion
- Patients with a history of any primary 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 uncontrolled high blood pressure - having anemia caused by conditions other than AIDS (for example, vitamin deficiency or bleeding from the gastrointestinal tract) - having a serum ferritin value \<30 ng/mL or an iron/total iron-binding capacity (Fe/TIBC) ratio less than 15%.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 1989
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00270270
End Date
July 1 1989
Last Update
May 18 2011
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