Phase 4
N=48
Study of Truvada for HIV Pre Exposure Prophylaxis Using Daily Directly Observed Therapy to Look at Potential Interactions Between Truvada and Hormone Therapy
HIV Prevention · Transgender Health
Bottom Line
View on ClinicalTrials.gov: NCT04050371 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Tenofovir Diphosphate Concentration in Dried Blood Spots (DBS) — 973.5; 1078 fmol/punch
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tenofovir Diphosphate Concentration in Dried Blood Spots (DBS) |
973.5; 1078 | — |
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 Prophylaxis (or PrEP) appeared to be lower in transgender women compared to Men who Have Sex with Men (MSM) in the iPrEx study, the landmark study of PrEP for HIV prevention. Concentrations were especially low among transgender women (TGW) reporting use of feminizing hormones. Reasons for the lower drug concentrations may be behavioral or biomedical, or a combination of both. While there are no systemic drug-drug interactions between TDF and oral contraception, there are known interactions involving these classes of medications with drug transporters that could affect drug concentrations in target tissues. Drug-drug interactions with natural estrogens and anti-androgenic agents used for gender affirming hormone therapy among transgender women have not been studied, neither have interactions between emtricitabine and female hormones. Concerns about the impact of PrEP on gender affirming hormone therapy is the main barrier for uptake of PrEP among transgender women. In addition, very little is known about TDF/FTC pharmacokinetics in transgender men using testosterone hormonal therapy. Drug-drug interactions with masculinizing hormones have never been properly investigated as trans gender men have not been formally involved in PrEP clinical trials or demonstrations projects.This small study will assess pharmacokinetic drug-drug interactions between tenofovir disoproxil fumarate/emtricitabine and cross-sex hormone therapy. The I-BrEATHe study is a substudy of the Triumph study, a culturally-relevant community-led PrEP demonstration project in transgender communities. The I- BrEATHe pharmacokinetic substudy will provide Truvada daily using directly observed therapy in 24 transgender women and 24 transgender men over a one month period, and will measure drug and hormone therapy levels in blood collected from participants.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04050371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.