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 @ 12:06 PM
Ignite Modification Date:
2025-12-24 @ 12:06 PM
NCT ID:
NCT00000861
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Topical and/or antifungal agents, except ketoconazole.
* Treatment, maintenance, or chemoprophylaxis with approved agents for OIs will be given as clinically indicated.
* Clinically indicated antibiotics, unless excluded.
* Systemic corticosteroid use for \<21 days for acute problems is permitted as clinically indicated. However, chronic systemic corticosteroid use should be avoided.
* Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF, filgrastim).
* Didanosine (ddI).
* Regularly prescribed medications, such as antipyretics, antidepressants, oral contraceptives, megestrol acetate, testosterone, or any other medication.
Patients must have:
* A working diagnosis of HIV infection.
* A CD4+ count between 200 and 500 cells/mm3.
* Signed, informed parental consent if patient is less than 18.
NOTE:
* The DAIDS Clinical Science Research Committee (CSRC) has deemed this protocol appropriate for prisoner enrollment.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following conditions or symptoms are excluded:
Febrile illness with temperature \> 38.5 degrees C (101.3 degrees F) within 3 days prior to study entry.
Concurrent Medication:
Excluded:
* Non-nucleoside reverse transcriptase inhibitors.
* Protease inhibitors except IDV.
* Rifabutin and rifampin.
* Ketoconazole.
* Terfenadine, astemizole, cisapride, triazolam and midazolam.
Patients with any of the following prior conditions are excluded:
* History of prior saquinavir (SQV) therapy for more than 14 days.
* History of any prior protease inhibitor therapy other than SQV.
* History of serious opportunistic infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00000861
Study Brief:
Protocol Section:
NCT00000861