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Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT04742816
Collaborator
(none)
42
Enrollment
1
Location
1
Arm
15.4
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
iohexoliohexol
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients Sub-Study
Actual Study Start Date :
Sep 17, 2020
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Blood concentration of tenofovir [Day 1]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC San Diego AntiViral Research Center (AVRC) San Diego California United States 92103

    Sponsors and Collaborators

    • University of California, San Diego

    Investigators

    • Principal Investigator: Nimish Patel, PharmD, UC San Diego AntiViral Research Center (AVRC)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nimish Patel, Assoc Prof Clinical, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT04742816
    Other Study ID Numbers:
    • CCTG 605s
    First Posted:
    Feb 8, 2021
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Mar 3, 2022