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:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT00002405
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* Documented HIV-1 infection.
* Evidence of failure or intolerance (have experienced a treatment-limiting toxicity) to standard protease inhibitor therapy and, in the judgment of the physician, be unable to construct a viable treatment regimen without APV.
* Consent of parent or guardian if less than 18 years old.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the patient unable to take oral medication.
* Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, which, in the opinion of the investigator, would compromise the safety of the patient.
* Hepatic failure.
* Renal failure requiring dialysis.
Patients with the following prior conditions are excluded:
History of clinically relevant pancreatitis or hepatitis within the last 6 months.
Prior Medication:
Excluded:
* Previous treatment with APV.
* Patients currently participating in, or who would qualify for or have access to, an enrolling study of APV (ACTG 398 and ACTG 400).
Risk Behavior:
Excluded:
Patients with current alcohol or illicit drug use which, in the investigator's opinion, may interfere with the patient's ability to comply with the requirements of the study.
Required:
Currently taking at least one nucleoside analogue or protease inhibitor, in addition to amprenavir.
Required:
* Received prior treatment with one or more protease inhibitors.
* Patient must be naive to at least one or more nucleoside analogue, non-nucleoside analogue, or protease inhibitor drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Study:
NCT00002405
Study Brief:
Protocol Section:
NCT00002405