A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

HIV Infections Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

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
• 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

• Cytopenias
• HIV Infections

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,