The Safety and Effectiveness of r-HuEPO in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic - Full Text View

Sponsored by:	Ortho Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002303

Purpose

To determine the safety and efficacy of erythropoietin administered to patients with AIDS or advanced AIDS related complex ARC and anemia.

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 r-HuEPO in Patients With AIDS or Advanced ARC and Anemia

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

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 HIV disease.
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.

Concurrent Medication:

Excluded:

Zidovudine (AZT) during the double-blind phase of the study.

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS 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.
Zidovudine (AZT) and during double-blind phase of study.

Clinical diagnosis of AIDS related anemia.

Clinical diagnosis of AIDS or advanced AIDS related complex (ARC).
Clinically stable for 1 month preceding study entry.

Substance abuse.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002303

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:	004D, H87-048
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002303 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Recombinant Proteins
Erythropoietin
Acquired Immunodeficiency Syndrome

Anemia
AIDS-Related Complex
Zidovudine

Study placed in the following topic categories:

Epoetin Alfa
Virus Diseases
Sexually Transmitted Diseases, Viral
Hematinics
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Anemia
Zidovudine
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

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
AIDS-Related Complex

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 July 02, 2009