Status:
COMPLETED
A Pharmacokinetic Evaluation of Tenofovir/Emtricitabine as HIV Pre-Exposure Prophylaxis in Transgender Women
Lead Sponsor:
University of Nebraska
Conditions:
HIV Prevention
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
Human immunodeficiency virus (HIV) persists worldwide as an immense health burden among vulnerable populations. HIV pre-exposure prophylaxis (PrEP) has offered the promise of limiting the global burde...
Detailed Description
PrEP is a critical component of comprehensive transgender medical care. The proposed open-label, intensive PK study will inform the pharmacologic impact of combining PrEP and concurrent feminizing hor...
Eligibility Criteria
Inclusion
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Self identify as a transgender woman.
- Receiving estradiol (oral/sublingual tablets or transdermal patches) with oral spironolactone for at least 3 months prior to study entry.
- Serum estradiol level \>100 pg/mL.
- Non-reactive 4th or 5th generation screening test for HIV.
- Adults (19 years or older).
- Able to read and speak English to ensure appropriate ability to obtain informed consent.
Exclusion
- Participants will not be included in the study if one, or more, of the following criteria are met:
- Use of drugs known to be contraindicated with TDF, FTC, estradiol, or spironolactone within 30 days of study entry. The study team will review all concomitant medications at screening based on the US Department of Health and Human Services drug interaction table and the drug product labeling.
- Use of injectable estradiol (valerate or cypionate).
- Presence of any active condition or clinically significant disease that, in the investigator's opinion, would compromise the subject's safety or outcome of the study, including qualifying for non-occupational post-HIV exposure prophylaxis.
- Signs or symptoms of acute HIV infection within the last 30 days.
- Laboratory values obtained within 30 days prior to study entry:
- Creatinine clearance (CrCl) less than 60 mL/min as estimated by the Cockcroft-Gault equation.
- Positive hepatitis B surface antigen and/or hepatitis C antibody.
- Alanine transaminase (ALT), Aspartate transaminase (AST) or alkaline phosphatase \> 5x the upper limit of normal (ULN).
- Hemoglobin \<10 g/dL.
- Platelets \<50,000/mm3.
Key Trial Info
Start Date :
January 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03270969
Start Date
January 5 2018
End Date
September 10 2018
Last Update
September 15 2023
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198