Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

University of California, San Diego42 enrolled

Overview

Will use a subset of the main study cohort of transgender or non-binary individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values, renal biomarkers, drug levels and directly measured renal function.

This cross-sectional sub-study will use a subset of the main study cohort of transgender (TG) or non-binary (NB) individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values (serum estradiol, estrone, free/total testosterone), renal biomarkers, drug levels (measured by tenofovir diphosphate, TFV-DP, and emtricitabine triphosphate, FTC-TP, on dried blood spot cards and urine) and directly measured renal function (iohexol clearance).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Transgender Renal Function Hormone Replacement Therapy

Interventions

IHX-CL measurementsDIAGNOSTIC_TEST

The distribution of measured IHX-CL values and other continuous variables will be assessed to ensure a parametric distribution.

IohexolDRUG

Iohexol clearance measurement

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HIV-uninfected * Identifying as transgender or nonbinary (TG/NB) * Age ≥ 18 years (adult) * At risk of acquiring HIV * Calculated creatinine clearance (CRCL) ≥ 60 mL/minute * Taking emtricitabine/tenofovir alafenamide * Willing to receive a small dose of iohexol * Willing to provide 30 mL blood and a urine sample Exclusion Criteria: * Allergy to iohexol * Use of concurrent medications that may interfere with iohexol such as metformin, amiodarone or beta-blockers * Anuric or unable to produce 30 mL of urine * Other condition that, in the opinion of the investigator, would put the participant at risk, complicate interpretation of study outcome data, or would otherwise interfere with participation or achieving the study objectives

Locations (1)

UC San Diego AntiViral Research Center (AVRC)

San Diego, California, United States

Outcomes

Primary Outcomes

Iohexol clearance

Rate of clearance (mL/min) of iohexol from the body after a small dose is administered subcutaneously. Iohexol clearance is the gold standard for measuring kidney function.

Time frame: Day 1

Secondary Outcomes

Blood concentration of tenofovir

Tenofovir concentrations in blood and blotted on dried blood spot cards.

Time frame: Day 1

Data from ClinicalTrials.gov

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