Status:
COMPLETED
Study of Truvada for HIV Pre Exposure Prophylaxis Using Daily Directly Observed Therapy to Look at Potential Interactions Between Truvada and Hormone Therapy
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
San Francisco AIDS Foundation
California HIV/AIDS Research Program
Conditions:
HIV Prevention
Transgender Health
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Truvada (Emtricitabine or FTC and tenofovir disoproxil fumarate or TDF) has been approved for HIV prevention since 2012. Drug concentrations after receipt of oral Truvada for HIV Pre Exposure Prophyla...
Detailed Description
BACKGROUND The TRIUMPH study, or trans Research-Informed communities United in the Mobilization for the Prevention of HIV, is a new study responding to a pressing need for culturally-relevant communit...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- All subjects:
- HIV antibody seronegative (negative HIV rapid test),
- 18 years or older,
- Has a smart phone with access to two-way video call capability,
- Willingness to be contacted for a short call every day for 4 weeks,
- Adequate renal function (creatinine clearance ≥ 60 ml/min estimated by the Cockcroft Creatinine Clearance Formula),
- Provides written informed consent,
- For Transgender women:
- Male assigned sex at birth, and self-reported current gender identity as "woman" or "transgender women", or other trans-feminine spectrum identity,
- Current feminizing Hormone Therapy (HT) use for at least 6 months,
- For Transgender men:
- Female assigned sex at birth, and self-reported current gender identity as "man" or "transgender man", or other trans-masculine spectrum identity,
- Current masculinizing Hormone Therapy (HT) use for at least 6 months with testosterone
- Exclusion Criteria
- Expects to change or discontinue current HT use during the 4 weeks study period,
- Signs of symptoms of acute viral syndrome,
- Use of FTC or TDF in the past 90 days
- Receiving ongoing therapy with any of the following:
- AntiRetroviral Therapy, including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy, aminoglycoside antibiotics, amphotericin B, cidofovir, systemic chemotherapeutic agents, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents
- Renal insufficiency documented as Creatinine Clearance \< 60 ml/min
- For masculine-spectrum identifying persons, positive pregnancy test at screening
- At enrollment, has any other condition or factor that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data; or otherwise interfere with achieving the study objectives.
Exclusion
Key Trial Info
Start Date :
August 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04050371
Start Date
August 3 2017
End Date
May 23 2018
Last Update
May 11 2021
Active Locations (1)
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1
San Francisco AIDS foundation
San Francisco, California, United States, 94103