Sex Hormone Therapy and Mucosal Tissues

Completed

Conditions studied: Hiv

In brief

The purpose of this research study is to better understand how sex hormone therapy that is used to treat women for menopausal symptoms, men with low testosterone, or as hormone therapy for transgender women, affects a class of medications called NRTIs (nucleoside reverse transcriptase inhibitors) used to treat and prevent HIV infection. The two most commonly used NRTIs are tenofovir and emtricitabine, which are the components of the drug Truvada and also included in the combination products Atripla, Complera, and Stribild. The medication's ability to work effectively may be altered when someone is also taking sex hormone therapy. In order to determine this effect, samples will be collected from some parts of the body where HIV makes copies. These samples will be measured for the levels of HIV medication, HIV virus and sex hormones that are present. The samples that will be looked at in this study include blood, cells from the vagina, semen, and tissue biopsies from the female genital tract and rectum.

Key facts

Study ID

NCT02983110

Run by

University of North Carolina, Chapel Hill

People needed

12

Starts

2016-11-01

Expected to finish

2018-10-15

Last updated by the study team

2018-12-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical and Translational Research Center, UNC Hospitals — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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