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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT00001057
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Antibiotics for bacterial infections as clinically indicated.
* Recombinant erythropoietin (EPO) and G-CSF as clinically indicated for grade 3 or worse anemia and neutropenia, respectively.
* Antipyretics.
* Analgesics.
* Allergy medications.
* Oral contraceptives.
* Nonprescription medications such as vitamins or herbal therapies.
Concurrent Treatment:
Allowed:
* Radiation therapy to local lesion only.
* Acupuncture.
Patients must have:
* HIV seropositivity.
* CD4 count \>= 550 cells/mm3.
* No ARC or AIDS conditions by CDC criteria.
* Consent of parent or guardian if less than 18 years of age.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Presence of factors predisposing to pancreatitis such as active alcoholism.
* Other medical conditions that would interfere with study compliance.
Concurrent Medication:
Excluded:
* Other antiretrovirals or systemic immunomodulators.
* Systemic corticosteroids.
* Systemic cytotoxic chemotherapy.
* Intravenous pentamidine.
Concurrent Treatment:
Excluded:
* Radiation therapy except to local lesion.
Patients with the following prior conditions are excluded:
* History of chronic diarrhea, defined as more than four loose or watery stools on average daily for the past month.
* History of grade 2 or worse peripheral neuropathy.
* History of pancreatitis.
* Bacterial infection requiring antibiotics within 14 days prior to study entry.
Prior Medication:
Excluded:
* Prior HIV therapy with antiretrovirals or systemic immunomodulators.
Prior Treatment:
Excluded within 2 weeks prior to study entry:
* Transfusion.
Active substance abuse or alcoholism.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00001057
Study Brief:
Protocol Section:
NCT00001057