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Study of Truvada for HIV Pre Exposure Prophylaxis Using Daily Directly Observed Therapy to Look at Potential Interactions Between Truvada and Hormone Therapy (I-BrEATHe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04050371
Recruitment Status : Completed
First Posted : August 8, 2019
Results First Posted : May 11, 2021
Last Update Posted : May 11, 2021
San Francisco AIDS Foundation
California HIV/AIDS Research Program
Information provided by (Responsible Party):
University of California, San Francisco

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 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.

Condition or disease Intervention/treatment Phase
HIV Prevention Transgender Health Drug: 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive Truvada for study duration and will take pills using daily observed therapy.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: I-BrEATHe - Interactions Between Antiretrovirals And Transgender Hormones
Actual Study Start Date : August 3, 2017
Actual Primary Completion Date : May 23, 2018
Actual Study Completion Date : May 23, 2018

Arm Intervention/treatment
Experimental: TRUVADA DOT
one tablet containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate as single dose with daily observed therapy performed either via video calling, or at study visit, for a total of 28 to 30 days
Drug: 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
All study participants received daily observed therapy with FTC/TDF.
Other Name: Truvada

Primary Outcome Measures :
  1. Tenofovir Diphosphate Concentration in Dried Blood Spots (DBS) [ Time Frame: After 4 weeks of daily observed dosing of FTC/TDF ]
    Tenofovir diphosphate concentration in dried blood spots at week 4

Other Outcome Measures:
  1. Estradiol Concentration [ Time Frame: Baseline and after 4 weeks of daily FTC/TDF ]
    Estradiol concentrations in blood plasma by LC-MS/MS

  2. Total Testosterone [ Time Frame: Baseline and after 4 weeks of daily FTC/TDF ]
    Total testosterone concentrations in blood plasma by LC-MS/MS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   transmen, transwomen and gender non conforming
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04050371

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United States, California
San Francisco AIDS foundation
San Francisco, California, United States, 94103
Sponsors and Collaborators
University of California, San Francisco
San Francisco AIDS Foundation
California HIV/AIDS Research Program
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Principal Investigator: Robert M Grant, MD, MPH University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Informed Consent Form  [PDF] October 13, 2017

Additional Information:
WHO Guidelines Approved by the Guidelines Review Committee, in Guideline on When to Start Antiretroviral Therapy and on Pre-Exposure Prophylaxis for HIV. 2015, World Health Organization. Copyright (c) World Health Organization 2015.: Geneva.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of California, San Francisco Identifier: NCT04050371    
Other Study ID Numbers: A131155
First Posted: August 8, 2019    Key Record Dates
Results First Posted: May 11, 2021
Last Update Posted: May 11, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, San Francisco:
Pre Exposure Prophylaxis
HIV prevention
Emtricitabine, Tenofovir Disoproxil Fumarate
transgender health
transgender persons
drug combination
drug combinations
non binary
daily observed therapy
Additional relevant MeSH terms:
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Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents