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Completed

NCT Number: NCT04742816

Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

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.

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Key information

Conditions

Transgender Hormone Replacement Therapy Renal Function

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UC San Diego AntiViral Research Center (AVRC)

San Diego, California, 92103, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IHX-CL measurements

Diagnostic Test

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

Other names: OMNIPAQUE, Iohexol

Iohexol

Drug

Iohexol clearance measurement

Other names: OMNIPAQUE

Primary outcomes

  1. Iohexol clearance

    Time frame: 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 outcomes

  1. Blood concentration of tenofovir

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2021
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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