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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002073
Other study ID # 004E
Secondary ID I88-009
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date December 1989
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

To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria

Concurrent Medication:

Allowed:

- Maintenance dose of zidovudine (AZT) of at least 400 mg daily.

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 AIDS.

- 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.

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.

- Must not have previously participated in any other r-HuEPO clinical studies.

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.

Clinical diagnosis of AIDS and related anemia.

- Clinical diagnosis of AIDS.

- Clinically stable for 1 month preceding study entry.

- Maintenance dose of zidovudine (AZT) of at least 400 mg daily.

Substance abuse.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Epoetin alfa


Locations

Country Name City State
United States Ortho Pharmaceutical Corp Raritan New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Ortho Pharmaceuticals

Country where clinical trial is conducted

United States, 

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