Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT00002303
Eligibility 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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00002303
Study Brief:
Protocol Section:
NCT00002303