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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT00001004
Eligibility Criteria:
Inclusion Criteria
Patients who have a primary diagnosis of AIDS related complex (ARC) including lymphadenopathy syndrome (LAS), who are positive for HIV antibody, have a minimum life expectancy of 3 months, and have one or more of the following symptoms for = or \> 30 days:
* Fever.
* Night sweats.
* Fatigue.
* Oral thrush.
* Hairy leukoplakia.
* Diarrhea.
* Weight loss \< 10 percent.
* Patients must be able to sign a written informed consent form, which must be obtained prior to treatment.
Concurrent Medication:
Allowed:
* Acetaminophen for temperature rise of \> 38.5 degrees C - 650 mg by mouth every 4 hours on an as needed basis.
Severe rigors may be treated (or prevented) with meperidine 50 mg IV on an as needed basis in the absence of systolic hypotension \< 80 mm Hg.
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Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
* Clinically significant cardiac disease - New York Heart Association Class II, III, or IV.
* Hemorrhagic diathesis (including hemophilia) or active bleeding disorder (e.g., genitourinary, gastrointestinal).
* Clinically apparent vascular disease (including a prior history of pulmonary embolus, deep venous thrombosis, or peripheral arterial occlusive disease).
Concurrent Medication:
Excluded:
* Medications required for the treatment of active cardiac disease including cardiac glycosides, antiarrhythmics and antianginal agents.
* Anticoagulants.
* Thrombolytic agents.
* Nonsteroidal anti-inflammatory drugs.
* Ongoing therapy with vasodilators.
* Aspirin.
* Corticosteroids.
* Antihistamines.
* Barbiturates.
* Excluded within 4 weeks of study entry:
* Antiviral chemotherapy.
* Immunotherapy.
* Excluded within 12 weeks of study entry:
* Suramin.
Patients with the following are excluded:
* AIDS-associated opportunistic infection.
* Lipoprotein disorders.
* Hemophilia.
Prior Medication:
Excluded:
* Interferon gamma.
* Tumor necrosis factor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00001004
Study Brief:
Protocol Section:
NCT00001004