Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients
NCT ID: NCT04742816
Last Updated: 2022-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
42 participants
INTERVENTIONAL
2020-09-17
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
IHX-CL measurements
The distribution of measured IHX-CL values and other continuous variables will be assessed to ensure a parametric distribution.
Iohexol
Iohexol clearance measurement
Interventions
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IHX-CL measurements
The distribution of measured IHX-CL values and other continuous variables will be assessed to ensure a parametric distribution.
Iohexol
Iohexol clearance measurement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Nimish Patel
Assoc Prof Clinical
Principal Investigators
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Nimish Patel, PharmD
Role: PRINCIPAL_INVESTIGATOR
UC San Diego AntiViral Research Center (AVRC)
Locations
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UC San Diego AntiViral Research Center (AVRC)
San Diego, California, United States
Countries
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Other Identifiers
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CCTG 605s
Identifier Type: -
Identifier Source: org_study_id
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