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The Safety and Effectiveness of r-HuEPO in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002303
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytopenias, HIV Infections

Keywords

Recombinant Proteins, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, AIDS-Related Complex, Zidovudine

Brief summary

To determine the safety and efficacy of erythropoietin administered to patients with AIDS or advanced AIDS related complex ARC and anemia.

Interventions

DRUGEpoetin alfa

Sponsors

Ortho Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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 HIV disease. * 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. Concurrent Medication: Excluded: * Zidovudine (AZT) during the double-blind phase of the study. 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. * Zidovudine (AZT) and during double-blind phase of study. Clinical diagnosis of AIDS related anemia. * Clinical diagnosis of AIDS or advanced AIDS related complex (ARC). * Clinically stable for 1 month preceding study entry. Substance abuse.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026