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
|First Received Date ICMJE||December 22, 2005|
|Last Updated Date||May 17, 2011|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Change in hemoglobin, hematocrit, and reticulocyte count (laboratory tests used to evaluate the severity of anemia); Transfusion requirements; Safety evaluations including adverse events|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00270270 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Patient's quality of life assessment|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||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|
|Official Title ICMJE||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 in AIDS patients for the treatment of anemia that is a result of the disease or a result of zidovudine (AZT) treatment for AIDS. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
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]). 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 study with an open-label follow-up period that is designed to evaluate the safety and effectiveness of epoetin alfa treatment compared with placebo treatment in patients with AIDS who are being treated with AZT. The study consists of three periods: a screening period to determine if patients are eligible for the study, a double-blind period, and an open-label period. During the double-blind period, patients are randomly assigned to one of two groups and receive either epoetin alfa (100 units per kilogram) or placebo injected into a vein (intravenously) three 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 (subcutaneously) for up to 6 months at the dose needed to maintain hematocrit levels of 38% to 40%. Effectiveness will be determined by the change in hemoglobin, hematocrit, and reticulocyte count (laboratory tests used to evaluate the severity of anemia), transfusion requirements, and the patient's quality of life assessment. Safety assessments include the incidence and severity of adverse events during the study, results of clinical laboratory tests (hematology, biochemistry, and urinalysis), measurements of vital signs, electrocardiograms (ECGs) and physical examination findings. The study hypothesis is that for treatment of anemia in patients with AIDS who are receiving AZT therapy, epoetin alfa is superior to placebo, as measured by changes in hemoglobin, hematocrit, and reticulocyte count, transfusion requirements, and the patient's quality of life.
Double-blind period: epoetin alfa (100 units per kilogram [U/kg] of body weight) or placebo, injected intravenously three times a week for 12 weeks. Open-label period: epoetin alfa injected under the skin for up to 6 months, with dose adjustments in the range of 0 to 1,500 U/kg as needed to maintain hematocrit levels of 38% to 40%.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Drug: epoetin alfa|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||July 1989|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Inclusion Criteria: - 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 Criteria: - 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%.
|Ages||18 Years to 75 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00270270|
|Other Study ID Numbers ICMJE||CR006070|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|
|Verification Date||April 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP