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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00013520
Eligibility Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
* Are HIV-positive.
* Have a viral load of at least 400 copies/ml within 90 days prior to study entry.
* Are at least 16 years old.
* Weigh at least 40 kg.
* Have a negative pregnancy test within 48 hours before starting study drugs, if female and able to have children.
* Agree to use 2 effective methods of birth control while taking, and for 3 months after stopping, the study medications.
* Provide written consent of a parent or guardian, if under 18 years of age.
Exclusion Criteria
Patients will not be eligible for this study if they:
* Have taken anti-HIV drugs in the past.
* Are allergic to any of the study drugs or ingredients.
* Are pregnant or breast-feeding.
* Have taken any of the following drugs within 14 days prior to study entry: amiodarone, astemizole, bepridil, cisapride, ergot or ergot derivatives, systemic itraconazole, systemic ketoconazole, midazolam, propoxyphene, quinidine, rifampin, terfenadine, thalidomide, triazolam, or St. John's wort.
* Have taken drugs that influence the immune system, HIV or other vaccines, or investigational drugs within 30 days prior to study entry. Prednisone at a dose of 10 mg or less daily is allowed.
* Have taken drugs or been hospitalized for serious infections or medical illnesses within 14 days prior to study entry.
* Have growths or tumors that require drug therapy.
* Have Pneumocystis carinii pneumonia that is not clinically stable and whose treatment is not completed at least 7 days prior to study entry.
* Have infections or medical illnesses that are not under control or that have not received complete treatment before study entry.
* Have any condition that, in the opinion of the investigator, would prevent them from properly participating in the study.
* Abuse drugs or alcohol.
* This study has been updated to exclude patients who are receiving systemic itraconazole and rifabutin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00013520
Study Brief:
Protocol Section:
NCT00013520