Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

Phase 4

Completed

• Conditions: Transgender; Renal Function; Hormone Replacement Therapy
• Interventions: Diagnostic Test: IHX-CL measurements; Drug: Iohexol

• Registration Number: NCT04742816
• Lead Sponsor: University of California, San Diego

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).

Study Timeline

• Study Start: 2020-09-17
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-08
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iohexol injection	IHX-CL measurements	The research pharmacist will prepare the iohexol injection in a 1cc tuberculin syringe, consisting of 0.5cc sterile water for injection (SWFI) and 0.5cc iohexol (Omnipaque 300). The study coordinator/personnel (licensed RN) will inject the iohexol dose into the subcutaneous tissue on the opposite arm used for blood sampling; the time will be recorded. The participant will be monitored for adverse events 30 minutes post iohexol administration at the AVRC. If the participant has not had any adverse event within 30 minutes, they will be asked to leave the AVRC and return within 2 hours and 55 minutes post Iohexol injection for lab collection.
Iohexol injection	Iohexol	The research pharmacist will prepare the iohexol injection in a 1cc tuberculin syringe, consisting of 0.5cc sterile water for injection (SWFI) and 0.5cc iohexol (Omnipaque 300). The study coordinator/personnel (licensed RN) will inject the iohexol dose into the subcutaneous tissue on the opposite arm used for blood sampling; the time will be recorded. The participant will be monitored for adverse events 30 minutes post iohexol administration at the AVRC. If the participant has not had any adverse event within 30 minutes, they will be asked to leave the AVRC and return within 2 hours and 55 minutes post Iohexol injection for lab collection.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Blood concentration of tenofovir	Day 1	Tenofovir concentrations in blood and blotted on dried blood spot cards.

Trial Locations

Locations (1)

UC San Diego AntiViral Research Center (AVRC); 🇺🇸 San Diego, California, United States