A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or advanced AIDS related complex (ARC) and anemia secondary to their disease.

Detailed Description

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Conditions

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HIV Infections Cytopenias

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Epoetin alfa

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of any primary hematologic disease.
* HIV disease related dementia.
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.
* Anemia attributable to factors other than HIV disease or zidovudine (AZT) therapy.
* Acute opportunistic infection.
* History of seizures.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease.

Concurrent Medication:

Excluded:

* Zidovudine (AZT) therapy during the double-blind phase of study.

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 HIV disease.
* HIV disease related dementia.
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.

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.
* Zidovudine (AZT) therapy and during the double-blind phase.

Clinical diagnosis with AIDS or AIDS related complex (ARC) and related anemia.

* Clinical diagnosis of AIDS or ARC.
* Clinically stable for 1 month preceding study entry.
* Patients should preferably be transfusion dependent.

Substance abuse.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Ortho Pharmaceutical Corp

Raritan, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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87-022

Identifier Type: -

Identifier Source: secondary_id

004F