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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002022
Other study ID # 004G
Secondary ID I88-083
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date February 1991
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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.

Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Epoetin alfa


Locations

Country Name City State
United States R W Johnson Pharmaceutical Research Institute Raritan New Jersey

Sponsors (1)

Lead Sponsor Collaborator
R W Johnson Pharmaceutical Research Institute

Country where clinical trial is conducted

United States, 

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