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:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT00001112
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Prophylactic antibiotics.
* Tylenol (650 mg orally every 6 hours as needed for temperature \> 38.5 degrees C).
* Meperidine (25 - 50 mg intravenously, once, for severe rigors if systolic blood pressure is \> 90 mmHg).
Patients must meet criteria for AIDS classification (CDC) category IV C-1.
* Patients must have had one or more prior opportunistic infections identified in surveillance definition of AIDS. Patients whose AIDS-defining illness is Kaposi's sarcoma are also eligible if they have previously had one of the secondary infectious diseases identified in category C-1.
Prior Medication:
Required:
* Patients must have been receiving zidovudine (AZT) on a stable dosage regimen for at least 8 weeks immediately preceding entry into study.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
* Clinically significant cardiac (= or \> class II, New York Heart Association) or peripheral vascular disease that requires treatment.
* Presence of an active opportunistic infection that requires treatment.
* Hemorrhagic diathesis or active bleeding disorder.
* Clinically apparent vascular disease.
Concurrent Medication:
Excluded:
* Medications required for treatment of active cardiac disease.
* Ongoing therapy with anticoagulants or thrombolytic agents.
Patients with the following are excluded:
* Clinically significant cardiac (= or \> class II, New York Heart Association) or peripheral vascular disease that requires treatment.
* Presence of an active opportunistic infection that requires treatment.
* Hemorrhagic diathesis or active bleeding disorder.
* Clinically apparent vascular disease.
Prior Medication:
Excluded within 4 weeks of study entry:
* Antiviral chemotherapy other than zidovudine.
* Excluded within 12 weeks of study entry:
* Immunosuppressive or cytotoxic therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00001112
Study Brief:
Protocol Section:
NCT00001112