A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Ortho Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002073

Purpose

To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.

Condition	Intervention
HIV Infections Cytopenias	Drug: Epoetin alfa

Study Type:	Interventional
Study Design:	Treatment, Double-Blind
Official Title:	A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

Resource links provided by NLM:

MedlinePlus related topics: AIDS Anemia

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Eligibility

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

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

Maintenance dose of zidovudine (AZT) of at least 400 mg daily.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

History of any primary hematologic disease.
Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS.
AIDS-related dementia.
Uncontrolled hypertension (diastolic blood pressure > 100 mmHg).
Presence of concomitant iron deficiency.
Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.
Acute opportunistic infection.
History of seizures.

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.

Must not have previously participated in any other r-HuEPO clinical studies.

Prior Medication:

Excluded within 30 days of study entry:

Experimental drug or experimental device.
Cytotoxic chemotherapy.
Excluded within 2 months of study entry:
Androgen therapy.

Clinical diagnosis of AIDS and related anemia.

Clinical diagnosis of AIDS.
Clinically stable for 1 month preceding study entry.
Maintenance dose of zidovudine (AZT) of at least 400 mg daily.

Substance abuse.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002073

Locations

United States, New Jersey
Ortho Pharmaceutical Corp
Raritan, New Jersey, United States, 088690602

Sponsors and Collaborators

Ortho Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	004E, I88-009
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002073 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Recombinant Proteins
Injections, Subcutaneous
Erythropoietin

Acquired Immunodeficiency Syndrome
Anemia
Zidovudine

Additional relevant MeSH terms:

Epoetin Alfa
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Hematinics
Hematologic Agents
Acquired Immunodeficiency Syndrome
Infection

Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 05, 2009