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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT00002195
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* HIV-positive status.
* Screening viral load \>= 10,000 copies/mm3 14 days prior to entry.
* CD4+ cell counts \>= 200 cells/mm3 14 days prior to entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Clinical diagnosis of AIDS (CDC 1993 Classification C).
Concurrent Medication:
Excluded:
Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.
Patients with the following prior conditions are excluded:
Clinically relevant hepatitis in the previous 6 months.
Prior Medication:
Excluded:
* Greater than 4 weeks of any nucleoside antiretroviral therapy.
* Previous therapy with an HIV protease inhibitor.
* Cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
* Immunomodulating agents within 3 months prior to entry.
Prior Treatment:
Excluded:
Radiotherapy within 4 weeks prior to entry.
Risk Behavior:
Excluded:
Current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002195
Study Brief:
Protocol Section:
NCT00002195