A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia

Sponsor

Ortho Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00002042

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or advanced AIDS related complex (ARC) and anemia secondary to their disease.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Cytopenias	Drug: Epoetin alfa	N/A

Study Design

Study Type:

Interventional

Masking:

Double

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 and Advanced ARC Patients With Anemia

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

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

Concurrent Medication:

Excluded:

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

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.
HIV disease related dementia.
Uncontrolled hypertension (diastolic blood pressure > 100 mmHg).
Presence of concomitant iron deficiency.