Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at San Diego, California
Dates
study started
estimated completion
Principal Investigator
by Nimish Patel

Description

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.

Official Title

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

Details

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).

Keywords

Transgender Renal Function Hormone Replacement Therapy IHX-CL measurements Iohexol Iohexol injection

Eligibility

You can join if…

Open to people ages 18-100

  • 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

You CAN'T join if...

  • 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

Location

  • UC San Diego AntiViral Research Center (AVRC) accepting new patients
    San Diego California 92103 United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04742816
Phase
Phase 4
Study Type
Interventional
Last Updated