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

O

Ortho Pharmaceuticals

Status

Completed

Conditions

Cytopenias
HIV Infections

Treatments

Drug: Epoetin alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002072
H87-037
004C

Details and patient eligibility

About

To determine the safety and efficacy of erythropoietin (r-HUEPO) administered to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

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.

Substance abuse.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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