Sex Hormone Therapy and Mucosal Tissues (SHAMT)

Inclusion Criteria:

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All subjects eligible to enroll must meet the following inclusion criteria, regardless of cohort:

• HIV-positive adults aged 18-65, inclusive on the date of screening, clinically healthy, with an intact gastrointestinal tract. Any screening test may be repeated once in the screening window to confirm or verify eligibility.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all the pertinent details of the study.
• Willing and able to comply with scheduled visits, treatment plan laboratory tests, and other trial procedures
• Subjects must not be actively involved in the conception process, currently pregnant/lactating/ or in the immediate post-partum period.
• Subjects must be willing to abstain from all sexual activity, and all intravaginal and intrarectal products for at least 72 hours prior to the sampling day, until seven days later

• HIV RNA viral load undetectable (<50 copies/mL or less per institution) within at least the previous six months prior to screening. Repeat HIV RNA Viral load testing may be conducted at screening, if indicated.

  -->80% adherent to their antiretroviral regimen per self-report, and a compliant diary card 5 days before intensive sampling

• Actively adherent to an antiretroviral regimen containing both tenofovir (TDF) and emtracitabine (FTC) for >1 month (if switched from previous regimen) or >3 months (if previously antiretroviral naive) as part of their standard clinic care
• Negative, or treated, sexually transmitted infections at screening including syphilis, gonorrhea, chlamydia, and trichomoniasis
• All subjects must have an estimated calculated creatinine clearance of (eCcr) at least 60mL/min by the Cockcroft-Gault formula
• No clinical or surgical abnormalities (i.e. hysterectomy) that would preclude sample collection
• Hemoglobin Grade 2 or lower, with no clinical significant medical issues that would preclude blood sampling
• Coagulation testing Grade 2 or lower, with no clinically significant medical issues that would preclude tissue sampling

Exclusion Criteria:

• Age outside of desired range
• Subject is HIV negative
• Impaired renal function, as documented with a creatinine clearance <60mL/min with the Cockcroft-Gault equation
• Receiving an antiretorivral regimen that does not include TDF/FTC, or adherent to a TDF/FTC regimen less than one month, or patient is unlikely to remain on this regimen during the sampling period
• Less than 80% adherence to anti-retroviral medications, and more than 3 missed doses in the month preceding enrollment
• Subject is not able or willing to follow the diet and lifestyle guidelines necessary for the study period
• Active, untreated, sexually transmitted infection, including syphilis, gonorrhea, chlamydia or trichomoniasis or symptomatic bacterial vaginosis
• Clinical, laboratory, or surgical abnormalities that would preclude sample collection (for example but not limited to: hysterectomy)
• Subjects actively involved in the conception process, currently pregnant or lactating, or immediately post-partum