Treatment Program for Anemia in AIDS Patients

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	R W Johnson Pharmaceutical Research Institute
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002022

Purpose

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

Condition	Intervention
HIV Infections Cytopenias	Drug: Epoetin alfa

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison
Official Title:	Treatment Program for Anemia in AIDS Patients

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:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002022

Locations

United States, New Jersey
R W Johnson Pharmaceutical Research Institute
Raritan, New Jersey, United States, 088690602

Sponsors and Collaborators

R W Johnson Pharmaceutical Research Institute

More Information

No publications provided

Study ID Numbers:	004G, I88-083
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002022 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Recombinant Proteins
Drugs, Investigational
Erythropoietin

Acquired Immunodeficiency Syndrome
Anemia
Zidovudine

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
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 November 27, 2009