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Treatment Program for Anemia in AIDS Patients

Primary Purpose

HIV Infections, Cytopenias

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epoetin alfa
Sponsored by
R W Johnson Pharmaceutical Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Recombinant Proteins, Drugs, Investigational, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, Zidovudine

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Life expectancy < 3 months. = or < grade 4 performance score. AIDS-related dementia. Uncontrolled hypertension. Acute symptomatic opportunistic infection or other AIDS-defining illness. Patients with the following are excluded: Life expectancy < 3 months. = or < grade 4 performance score. AIDS-related dementia. Uncontrolled hypertension. Acute symptomatic opportunistic infection or other AIDS-defining illness. Patients must have: A clinical diagnosis of AIDS. Hematocrit < 30 percent. Endogenous serum erythropoietin level = or < 500 U/ml. A life expectancy = or > 3 months. > Grade 4 performance score.

Sites / Locations

  • R W Johnson Pharmaceutical Research Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
R W Johnson Pharmaceutical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00002022
Brief Title
Treatment Program for Anemia in AIDS Patients
Official Title
Treatment Program for Anemia in AIDS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 1991
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
R W Johnson Pharmaceutical Research Institute

4. Oversight

5. Study Description

Brief Summary
The objective of the Eprex (erythropoietin) Treatment Program is to provide erythropoietin for the treatment of anemia in AIDS patients.

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, Drugs, Investigational, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Epoetin alfa

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Life expectancy < 3 months. = or < grade 4 performance score. AIDS-related dementia. Uncontrolled hypertension. Acute symptomatic opportunistic infection or other AIDS-defining illness. Patients with the following are excluded: Life expectancy < 3 months. = or < grade 4 performance score. AIDS-related dementia. Uncontrolled hypertension. Acute symptomatic opportunistic infection or other AIDS-defining illness. Patients must have: A clinical diagnosis of AIDS. Hematocrit < 30 percent. Endogenous serum erythropoietin level = or < 500 U/ml. A life expectancy = or > 3 months. > Grade 4 performance score.
Facility Information:
Facility Name
R W Johnson Pharmaceutical Research Institute
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
088690602
Country
United States

12. IPD Sharing Statement

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Treatment Program for Anemia in AIDS Patients

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