Status:
COMPLETED
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
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 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 1989
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00269945
End Date
January 1 1989
Last Update
May 18 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.