Completed

r-HuEPO 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 experience anemia, a condition where the blood lacks enough healthy red blood cells, either due to the disease itself or because of their zidovudine (AZT) therapy. The main goal is to evaluate the safety and effectiveness of a drug called erythropoietin, or r-HuEPO, in treating this anemia. The potential outcomes of this research could provide a new approach to manage anemia in AIDS patients, improving their quality of life and overall care. During the study, participants receive erythropoietin through subcutaneous injections, a method similar to insulin injections for diabetes. The effectiveness of the treatment is measured by observing the correction of anemia and a reduction in the need for blood transfusions. The safety of the drug is also monitored throughout the study.

NCT00002302
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

4 inclusion criteria required to participate
Clinical diagnosis of AIDS
Clinical diagnosis of AIDS related anemia
Clinically stable for 1 month preceding study entry
Maintenance dose of zidovudine (AZT) of at least 400 mg daily
12 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 2 locations

AIDS Research Consortium of Atlanta

Atlanta, United StatesOpen AIDS Research Consortium of Atlanta in Google Maps

Ortho Pharmaceutical Corp

Raritan, United States
Completed2 Study Centers