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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00269945
First received: December 22, 2005
Last updated: May 17, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Anemia
Acquired Immunodeficiency Syndrome
Drug: epoetin alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 60
Study Completion Date: January 1989
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269945

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00269945     History of Changes
Other Study ID Numbers: CR005836
Study First Received: December 22, 2005
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anemia
AIDS
HIV
Zidovudine
Quality of Life
erythropoietin
epoetin alfa

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Anemia
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Hematologic Diseases
Antiviral Agents
Zidovudine
Epoetin Alfa
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Hematinics
Hematologic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 24, 2014