Status:
COMPLETED
Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients
Lead Sponsor:
University of California, San Diego
Conditions:
Transgender
Renal Function
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
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 biomarke...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04742816
Start Date
September 17 2020
End Date
December 31 2021
Last Update
March 3 2022
Active Locations (1)
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1
UC San Diego AntiViral Research Center (AVRC)
San Diego, California, United States, 92103