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

Primary Purpose

HIV Infections, Cytopenias

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epoetin alfa
Sponsored by
Ortho Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Recombinant Proteins, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, AIDS-Related Complex, Zidovudine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ortho Pharmaceutical Corp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Ortho Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00002303
Brief Title
The Safety and Effectiveness of r-HuEPO in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 1989
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ortho Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Cytopenias
Keywords
Recombinant Proteins, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, AIDS-Related Complex, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Epoetin alfa

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ortho Pharmaceutical Corp
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
088690602
Country
United States

12. IPD Sharing Statement

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

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