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Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04742816
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Nimish Patel, 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.

Condition or disease Intervention/treatment Phase
Transgender Renal Function Hormone Replacement Therapy Diagnostic Test: IHX-CL measurements Drug: Iohexol 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: iohexol
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients Sub-Study
Actual Study Start Date : September 17, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Iohexol

Arm Intervention/treatment
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 Name: OMNIPAQUE




Primary Outcome Measures :
  1. Iohexol clearance [ Time Frame: 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 [ Time Frame: Day 1 ]
    Tenofovir concentrations in blood and blotted on dried blood spot cards.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742816


Contacts
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Contact: Leah B Burke, MPH 619-543-8207 lbburke@health.ucsd.edu
Contact: Karen K Chow, BS 619-543-5320 kkchow@health.ucsd.edu

Locations
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United States, California
UC San Diego AntiViral Research Center (AVRC) Recruiting
San Diego, California, United States, 92103
Contact: Leah B Burke, MPH    619-543-8207    lbburke@health.ucsd.edu   
Contact: Helene T Le    619-543-3116    helenele@health.ucsd.edu   
Principal Investigator: Nimish Patel, PharmD         
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Nimish Patel, PharmD UC San Diego AntiViral Research Center (AVRC)
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Responsible Party: Nimish Patel, Assoc Prof Clinical, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04742816    
Other Study ID Numbers: CCTG 605s
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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