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| Sponsor: | Ortho Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002042 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections Cytopenias |
Drug: Epoetin alfa |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind |
| Official Title: | 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 30 days of study entry:
Clinical diagnosis with AIDS or AIDS related complex (ARC) and related anemia.
Substance abuse.
Contacts and Locations
More Information
| Study ID Numbers: | 004F, 87-022 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002042 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Recombinant Proteins Erythropoietin Acquired Immunodeficiency Syndrome |
Anemia AIDS-Related Complex Zidovudine |
|
Epoetin Alfa RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Hematinics Hematologic Agents Acquired Immunodeficiency Syndrome Infection |
Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |