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Trial record 1 of 1 for:    NCT03270969
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A Pharmacokinetic Evaluation of Tenofovir/Emtricitabine as HIV Pre-Exposure Prophylaxis in Transgender Women

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ClinicalTrials.gov Identifier: NCT03270969
Recruitment Status : Completed
First Posted : September 1, 2017
Last Update Posted : December 19, 2018
Information provided by (Responsible Party):
Kimberly Scarsi, PharmD, MS, BCPS-ID,, University of Nebraska

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 burden of HIV. The objective of this proposal is to conduct a pharmacokinetic (PK) study in transgender women to describe the pharmacokinetics of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as PrEP within this population.

Condition or disease Intervention/treatment Phase
HIV Prevention Drug: Tenofovir Disoproxil Fumarate/Emtricitabine Phase 1

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 hormone regimens. The investigators hypothesize transgender women will achieve similar PrEP concentrations compared to the historical controls, and that hormone concentrations (estrogen and testosterone) will not be affected. The aims of this study are to (1) to determine if concurrent use of TDF/FTC as PrEP in combination with feminizing hormones alters the PK of tenofovir (TFV) and FTC and (2) to determine if concurrent use of PrEP with feminizing hormones alters serum estradiol and testosterone concentrations. To achieve these aims, this study will enroll transgender women who are receiving either oral/sublingual or transdermal estradiol with spironolactone. Using intensive PK sampling, plasma and intracellular TDF/FTC concentrations will be measured after 14 days of oral TDF/FTC.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics of Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Pre-exposure Prophylaxis in Transgender Women Receiving Feminizing Hormone Therapy
Actual Study Start Date : January 5, 2018
Actual Primary Completion Date : September 10, 2018
Actual Study Completion Date : September 10, 2018

Arm Intervention/treatment
Experimental: TDF/FTC
Tenofovir Disoproxil Fumarate/Emtricitabine group HIV-uninfected transgender women receiving feminizing hormone therapy plus tenofovir disoproxil fumarate/emtricitabine
Drug: Tenofovir Disoproxil Fumarate/Emtricitabine
Participants will receive daily TDF/FTC for 14 days

Primary Outcome Measures :
  1. TFV plasma exposure [ Time Frame: 14 days ]
    Intensive PK sampling compared to historical controls

Secondary Outcome Measures :
  1. FTC plasma exposure [ Time Frame: 14 days ]
    Intensive PK sampling compared to historical controls

  2. Tenofovir-diphosphate (TFV-DP) intracellular concentrations [ Time Frame: 14 days ]
    Peripheral blood mononuclear cells (PBMC) concentrations compared to historical control

  3. Emtricitabine-triphosphate (FTC-TP) intracellular concentrations [ Time Frame: 14 days ]
    Peripheral blood mononuclear cells (PBMC) concentrations compared to historical control

  4. TFV maximum plasma concentration (Cmax) [ Time Frame: 14 days ]
    Cmax of TFV compared to historical control

  5. FTC maximum plasma concentration (Cmax) [ Time Frame: 14 days ]
    Cmax of FTC compared to historical control

  6. Estradiol serum concentrations [ Time Frame: 14 days ]
    Before and after intervention

  7. Testosterone serum concentrations [ Time Frame: 14 days ]
    Before and after intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   transgender women
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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.

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 ClinicalTrials.gov identifier (NCT number): NCT03270969

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United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kimberly Scarsi, PharmD, MS, BCPS-ID,, Postdoctoral Research Associate, University of Nebraska
ClinicalTrials.gov Identifier: NCT03270969    
Other Study ID Numbers: 491-17-FB
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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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.: Yes
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