Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

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

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.

Study Overview

• Status: Completed
• Conditions: Hormone Replacement Therapy; Renal Function; Transgender
• Intervention / Treatment: Diagnostic test: IHX-CL measurements; Drug: Iohexol

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UC San Diego AntiViral Research Center (AVRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Iohexol injection; 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.

Diagnostic test: IHX-CL measurements; The distribution of measured IHX-CL values and other continuous variables will be assessed to ensure a parametric distribution.; Other Names: OMNIPAQUE; Iohexol; Drug: Iohexol; Iohexol clearance measurement; Other Names: OMNIPAQUE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood concentration of tenofovir	Tenofovir concentrations in blood and blotted on dried blood spot cards.	Day 1

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Nimish Patel, PharmD, UC San Diego AntiViral Research Center (AVRC)

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 17, 2020
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (ACTUAL): February 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CCTG 605s

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No