Completed

Erythropoietin Safety and Efficacy in AIDS-Related Anemia

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What is being tested

Epoetin alfa

Drug
Who is being recruted

Blood-Borne Infections+17

+ Urogenital Diseases

+ Genital Diseases

From 18 to 75 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorOrtho Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on AIDS patients who have anemia, a condition where the body lacks enough healthy red blood cells. This anemia can be caused by the disease itself or by a medication called zidovudine (AZT) used in their treatment. The goal of the study is to test the safety and effectiveness of a drug called erythropoietin (r-HuEPO) in helping these patients. Erythropoietin is a hormone that helps the body produce more red blood cells. By testing this drug, the study aims to find a way to correct anemia and reduce the need for blood transfusions in AIDS patients, improving their overall care and quality of life.

NCT00002073
Principal SponsorOrtho Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesHematologic DiseasesHemic and Lymphatic DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsCytopeniaAcquired Immunodeficiency SyndromeAnemiaHIV Infections

Criteria

3 inclusion criteria required to participate
Clinical diagnosis of AIDS
Clinically stable for 1 month preceding study entry
Maintenance dose of zidovudine (AZT) of at least 400 mg daily
13 exclusion criteria prevent from participating
AIDS-related dementia
Acute opportunistic infection
Androgen therapy within 2 months of study entry
Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Ortho Pharmaceutical Corp

Raritan, United StatesOpen Ortho Pharmaceutical Corp in Google Maps
CompletedOne Study Center