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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT00096850
Eligibility Criteria:
Note: As of 11/27/06, enrollment into Version 1.0 of the study is now closed. Any new study participants will enroll under Version 2.0.
Inclusion Criteria:
* HIV uninfected
* Normal creatinine clearance
* Willing to use acceptable means of contraception during the study and for at least 6 weeks after stopping study medications
Exclusion Criteria:
* Using or anticipating use of certain medications, including any medication metabolized by CYP3A
* Active drug use or dependence that, in the opinion of the investigator, may interfere with the study
* Cannot stop consuming alcoholic beverages, grapefruit, or grapefruit juice for the duration of the study
* Cannot stop consuming coffee or caffeine-containing products for 12 hours prior to Day 8, 19, and 27 PK studies
* Serious illness that, in the opinion of the investigator, may interfere with the study
* Hospitalization for any reason within 14 days prior to study entry
* History of hypersensitivity to study drugs or their formulations
* Active or previous history of cardiovascular, kidney, liver, blood, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease. Patients with chronic illnesses such as hypertension, coronary heart disease, arthritis, diabetes, or chronic gastrointestinal conditions that may affect drug absorption are also excluded.
* ECG showing first-degree or greater heart block or a QT interval greater than 440 msec within 30 days of study entry
* Previous participation in this study
* Pregnancy or breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00096850
Study Brief:
Protocol Section:
NCT00096850