Sex Hormone Therapy and Mucosal Tissues — SHAMT  

Hiv Clinical Trial

Official title: Does Sex Hormone Therapy Decrease Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Active Metabolite Formation in Mucosal Tissues?

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Study Design:

This is an observational study of tenofovir/emtricitabine (TFV/FTC) concentrations in the genital and lower gastrointestinal tracts. Participants will be selected on the basis of receiving TFV/FTC as part of their ongoing HIV care. After participant education, informed consent, and screening for study eligibility, participants will be evaluated at baseline. All samples will be collected over the course of an outpatient sampling visit.

Study Sampling:

1. A blood sample will be collected to measure the concentration of TFV/FTC in the blood plasma, the concentration of TFV/FTC active metabolite concentrations (TFVdp/FTCtp) in the PBMCs, and the concentration of sex hormones in the blood stream.

2. Vaginal and cervical tissue will be collected (for cisgender women) to measure for concentrations of TFVdp/FTCtp, HIV RNA, and estrogen/progesterone.

3. Rectal tissue samples will be collected to measure for concentrations of TFVdp/FTCtp, HIV RNA, estrogen/progesterone (for cisgender and transgender women), and testosterone (for cisgender men).

4. A semen sample will be collected (for cisgender men) to measure the concentrations of TFV/FTC, HIV RNA and testosterone.

Pharmacokinetic Analysis:

All blood, cervical, vaginal, semen and rectal tissue samples will be analyzed by the Clinical Pharmacology and Analytical Chemistry Laboratory (CPAC) at the UNC School of Pharmacy. TFV/FTC will be measured in blood and seminal plasma and TFVdp/FTCtp will be measured in PBMCs, SMCs using validated LC-MS/MS methods. HIV RNA will be measured in blood and seminal plasma using the Abbott Real Time HIV-1 quantitative assay. HIV RNA within the cervical and seminal cells and rectal tissues will be measured using an established Droplet Digital PCR method. Estradiol and progesterone will be measured in serum using validated florescent immunoassays. ;

Related Conditions & MeSH terms

• Hiv

• NCT number: NCT02983110
• Study type: Observational
• Source: University of North Carolina, Chapel Hill
• Status: Completed
• Start date: November 2016
• Completion date: October 15, 2018