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NCT04742816 Clinical Trial

Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

Renal Function Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04742816
Other study ID # CCTG 605s
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 17, 2020
Est. completion date December 31, 2021

Study information
Verified date March 2022
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• IHX-CL measurements
The distribution of measured IHX-CL values and other continuous variables will be assessed to ensure a parametric distribution.
Drug:
• Iohexol
Iohexol clearance measurement

Locations
Country Name City State
United States UC San Diego AntiViral Research Center (AVRC) San Diego California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Day 1
Secondary Blood concentration of tenofovir Tenofovir concentrations in blood and blotted on dried blood spot cards. Day 1
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