r-HuEPO Safety and Efficacy in AIDS-Related Anemia
Epoetin alfa
Blood-Borne Infections+17
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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 AIDS itself or by the medication AZT used to treat AIDS. The study aims to evaluate the safety and effectiveness of a drug called erythropoietin (r-HUEPO) in managing this condition. The potential outcomes of this study could lead to improved care for AIDS patients suffering from anemia, addressing a common challenge associated with the disease and its treatment. During the study, participants receive either r-HUEPO or a placebo, a substance that has no therapeutic effect. Neither the participants nor the researchers know who receives which, ensuring the results are unbiased. The study measures the safety and effectiveness of r-HUEPO by observing changes in the participants' health. The effectiveness is determined by assessing improvements in anemia, while safety is evaluated by monitoring any side effects or complications.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
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 AIDS. 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. 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. Clinical diagnosis of AIDS and related anemia. Clinical diagnosis of AIDS. Clinically stable for 1 month preceding study entry. Substance abuse.
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