Trial | NCT00002071  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    epoetin ...

  • Study Participants

    None
To determine the safety and efficacy of erythropoietin administered to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.
Study Started
Nov 02
1999
Last Update
Jun 24
2005
Estimate

Drug Epoetin alfa

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 related anemia.

Clinical diagnosis of AIDS.
Clinically stable for 1 month preceding study entry.

Substance abuse.
No Results Posted