Hormone Replacement Therapy, Renal Function, Transgender
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DIAGNOSTIC_TESTIHX-CL measurements
The distribution of measured IHX-CL values and other continuous variables will be assessed to ensure a parametric distribution.
DRUGIohexol
Iohexol clearance measurement
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
iohexol
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Iohexol clearance | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood concentration of tenofovir | Day 1 | Tenofovir concentrations in blood and blotted on dried blood spot cards. |
Countries
United States
Outcome results
None listed