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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT00448669
Eligibility Criteria:
Inclusion Criteria:
* citizen of Botswana 18-39 years old
* sexually active
* HIV uninfected
* Hepatitis B and C uninfected
* Calculated creatinine clearance \>= 60 mL/min
* hemoglobin \>= 8 gm/dL
* ALT and AST \<= 2x ULN
* total bilirubin \<= 1.5 mg/dL
* total serum amylase \<= 1.5x ULN
* Serum phosphorus \>= 2.2 mg/dL
* willing to use hormonal contraception (females)
* living within 1 hours travel of study clinic
* pass comprehension test
* willing and able to give informed consent
Exclusion Criteria:
* 18-20 without parent/guardian consent
* history of significant renal or bone disease
* any chronic illness requiring ongoing prescription medication
* pregnant or breastfeeding
* planning to move away from site in the next year
* participating in another HIV prevention or vaccine safety trial
* any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT00448669
Study Brief:
Protocol Section:
NCT00448669