Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Acquired Immunodeficiency Syndrome
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 for the treatment of anemia in AIDS (Acquired Immunodeficiency Syndrome) patients with anemia that ...
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, AZT). Anemia is a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 1989
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00270010
End Date
August 1 1989
Last Update
May 18 2011
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