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 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT00002161
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* HIV infection with HIV RNA titer \>= 2500 copies/ml (2.5 KEq/ml) plasma.
* CD4 count \>= 200 cells/mm3.
* No new AIDS-defining event within the past 2 months.
* Life expectancy at least 1 year.
* Consent of parent or guardian if less than 18 years old.
* Tolerated antiretroviral therapy for the past 2 months.
NOTE:
* Kaposi's sarcoma is permitted provided patient has not received systemic therapy within the past month.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Active, serious infections other than HIV that require parenteral antibiotic or antiviral therapy.
* Gastrointestinal malabsorption syndrome or chronic nausea or vomiting that would preclude oral medication.
* Malignancy other than Kaposi's sarcoma or basal cell carcinoma.
Concurrent Medication:
Excluded:
* Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
* Isoniazid.
* Rifampin.
* Investigational agents (unless approved by sponsor).
* Systemic chemotherapeutic agents.
Prior Medication:
Excluded:
* Parenteral antibiotic or antiviral therapy for another active, serious infection within the past 2 weeks.
* Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons within the past month.
* Systemic therapy for KS within the past month.
Required:
* Antiretroviral regimen other than study drug.
Required:
* Antiretroviral therapy for at least the past 2 months. Current alcohol or substance abuse that would interfere with compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00002161
Study Brief:
Protocol Section:
NCT00002161