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Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients | Clinical Trials | Clareo Health

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Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients Sub-Study

NCT04742816•University of California, San Diego

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).

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

September 17, 2020

Primary Completion Date

December 31, 2021

Completion Date

December 31, 2021

Last Updated

March 3, 2022

Enrollment

ACTUAL participants

Conditions

TransgenderRenal FunctionHormone Replacement Therapy

Interventions

IHX-CL measurements

DIAGNOSTIC_TEST

Iohexol

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

Inclusion Criteria

Exclusion Criteria

The Effect of Gender-affirmative Measures on Breast Perception in Trans Men

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