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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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002042
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1989

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002042 on ClinicalTrials.gov Archive Site
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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
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

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.

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Interventional
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Masking: Double-Blind
Primary Purpose: Treatment
  • HIV Infections
  • Cytopenias
Drug: Epoetin alfa
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002042
004F, 87-022
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Ortho Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
December 1989

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP