The Safety and Effectiveness of r-HuEPO in Patients With AIDS and Anemia Caused by AIDS and Treatment With AZT - Full Text View

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

MedlinePlus related topics:

AIDS Anemia

ChemIDplus related topics:

Zidovudine Epoetin alfa Erythropoietin

U.S. FDA Resources

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

Eligibility

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

Criteria

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.

Patients who have previously participated in any other r-HuEPO clinical study are excluded.

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 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: NCT00002302

Locations


United States, Georgia
	AIDS Research Consortium of Atlanta
	Atlanta, Georgia, United States, 30308

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

Sponsors and Collaborators

Ortho Pharmaceuticals

More Information

Publications:

Rarick M, Wilson E, Bernstein-Singer M, Gill PS, Muggia F, Levine AM. Double-blind placebo controlled study of recombinant human erythropoietin in AIDS patients with anemia caused by HIV infection and zidovudine. Int Conf AIDS. 1989 Jun 4-9;5:195 (abstract no MBO48)

Study ID Numbers:	004B, 87-021
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002302
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

Study placed in the following topic categories:

Epoetin Alfa

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Anemia

Zidovudine

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Hematinics

Therapeutic Uses

Hematologic Agents

Lentivirus Infections

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	Ortho Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002302