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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT00697892
Eligibility Criteria:
Inclusion Criteria:
* Absence of HIV infection prior to study entry
* Male or female aged 21-60 who are able to provide informed consent
* Subject is within 20% (+/-) of ideal body weight and weighs at least 50 kg.
* Healthy, without evidence of acute or chronic illness including diabetes, hypertension, CAD, psychiatric illnesses, renal or hepatic impairment.
* Screening laboratory tests that are normal or deemed not clinically significant by the study physician.
* Female subjects of reproductive potential must agree to the use of two forms of birth control methods for at least one month prior to study enrollment and for 6 weeks following study completion
* Female subjects must have a negative pregnancy test within 24 hours before receiving any study drugs.
Exclusion Criteria:
* Use of illicit drugs or alcohol that could interfere with the completion of the study
* Use of any over-the-counter or prescribed drugs unless approved by the principal investigator or study physician
* Use of drugs that are known to inhibit/induce CYP450 isozymes or are substrates of CYP3A4, CYP2D6, CYP2C8 enzymes (use of hormonal contraceptives is permitted).
* Pregnant or breastfeeding
* History of acute or chronic illnesses, such as diabetes, hypertension, CAD, psychiatric illnesses, renal or hepatic impairment.
* Evidence of acute illness
* Family history of congenital prolongation of QTc interval or with any conditions known to prolong QTc interval such as cardiac arrhythmias, bradycardia, or severe heart disease
* History of hypokalemia, hypomagnesemia, or hypercholesteremia
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT00697892
Study Brief:
Protocol Section:
NCT00697892