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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT00002220
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* Serologically documented HIV infection.
* Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml.
* Parental consent for patients under 18.
Nelfinavir-Failure Group:
* Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent.
* Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold).
Control Group:
* Must have received any combination of currently licensed nucleoside reverse transcriptase inhibitors for at least 16 weeks.
* Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's.
Exclusion Criteria
Prior Medication:
Excluded:
Control group:
* Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors.
Required:
Nelfinavir-failure patients:
* At least 16 weeks of nelfinavir.
Control group:
* At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00002220
Study Brief:
Protocol Section:
NCT00002220