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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT02638493
Eligibility Criteria:
Inclusion Criteria:
* Born male between the ages of 18 and 60
* HIV positive taking TDF/FTC (and a third drug) as treatment; or HIV negative men receiving TDF/FTC as pre-exposure prophylaxis; HIV positive men taking tenofovir alafenamide
* if on routine treatment must have been taking medication for at least 3 months and adherence to medication as assessed by blood plasma HIV RNA less than 50 copies per mL.
* documentation of at least 80% adherence to antiretroviral (ART) regimen, through clinician or self-report, with no missed doses in the 3 days prior to the inpatient visit.
* willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that would pose unnecessary risk or interfere with study results.
* unwilling or unable to abstain from sexual activity 72 hours prior to overnight sampling visit
* unlikely to remain on current drug regimen during study period
* anemia that precludes blood donation
* unable to provide semen specimen
* current receipt of other medications that may affect endogenous nucleotide concentrations, such as additional HIV nucleoside reverse transcriptase inhibitors, ribavirin, or adefovir
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02638493
Study Brief:
Protocol Section:
NCT02638493