- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00269945
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
May 17, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-up to Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 condition in which a patient has below normal levels of hemoglobin, the substance in red blood cells that carries oxygen to all parts of the body.
People with severe anemia may experience fatigue and shortness of breath with activity.
Therefore, this condition can have a negative influence on a person's quality of life.
Epoetin alfa, used to treat anemia, is a genetically engineered form of a natural hormone, erythropoietin, that stimulates red blood cell production.
This is a randomized, double-blind, placebo-controlled, parallel group study with an open-label follow-up period that is designed to evaluate the safety and effectiveness of epoetin alfa treatment in patients with AIDS who are being treated with AZT.
The study consists of 3 periods: a screening period to determine if patients are eligible for the study, a double-blind period, and an open-label period.
Eligible patients will be randomly assigned to one of two groups: a group receiving epoetin alfa 100 U/kg or a group receiving matching placebo.
Patients will be treated with study medication injected under the skin 3 times per week for 12 weeks (or until their hematocrit reaches 38% to 40%).
In the open-label period, all patients receive epoetin alfa injected under the skin for up to 6 months.
Effectiveness will be determined by the change in hemoglobin, hematocrit, and reticulocytes (laboratory tests used to evaluate the severity of anemia), transfusion requirements, the patient's quality of life assessment, and the physician's global evaluation of the drug effect.
Safety assessments include the incidence and severity of adverse events during the study, and changes in clinical laboratory tests (hematology, biochemistry, and urinalysis), vital signs, electrocardiograms (ECGs), and physical examination findings.
The study hypothesis is that AIDS patients who are receiving AZT and who are treated with epoetin alfa will have a lower incident of anemia compared with patients receiving placebo.
Double-blind: epoetin alfa (100 U/kg) or placebo given under the skin 3 times a week for 12 weeks or until hematocrit reaches 38% to 40%.
Open-label: epoetin alfa 150 U/kg 3 times a week for up to 6 months (once weekly after hematocrit reaches 38% to 40%).
Dosage may be adjusted up to 300 U/kg.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change in hemoglobin, hematocrit, and reticulocytes (laboratory tests used to evaluate the severity of anemia), transfusion requirements, and patient's quality of life assessment.
|
Secondary Outcome Measures
Outcome Measure |
---|
Adverse events; changes in clinical laboratory tests, vital sign measurements, ECGs, and physical examination findings; and physician's global evaluation of the overall effect of the drug
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion (Actual)
January 1, 1989
Study Registration Dates
First Submitted
December 22, 2005
First Submitted That Met QC Criteria
December 22, 2005
First Posted (Estimate)
December 26, 2005
Study Record Updates
Last Update Posted (Estimate)
May 18, 2011
Last Update Submitted That Met QC Criteria
May 17, 2011
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Hematologic Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Anemia
- Hematinics
- Epoetin Alfa
Other Study ID Numbers
- CR005836
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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