Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women

NCT ID: NCT03060785

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-08
• Study Completion Date: 2018-05-31

Brief Summary

This is an open-label, steady-state study of Tenofovir (TFV) and Emtricitabine (FTC) pharmacokinetics (PK) in transgender women taking feminizing hormones. Half of the participants will be transgender women on feminizing hormones, the other half will be male volunteers not taking any hormone therapy.

Detailed Description

The investigators propose an open-label, steady-state study of TFV and FTC PK in blood and colon tissue in healthy TGW on feminizing hormones to be compared to healthy cis men, all at risk for HIV infection. Research participants will already have received eight days of TDF/FTC dosing. Evaluating TDF and FTC PK at steady-state is important as it reduces inter-individual variability since the rate of phosphorylation of TFV and FTC is highly variable, resulting in highly variable TFV-DP and Emtricitabine-Triphosphate (FTC-TP) PK among individuals in the first day and during rise to steady-state.

Conditions

HIV Prevention

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

TFV/FTC dosing in Transgender women

Single daily dose of oral Tenofovir Disoproxil Fumarate/Emtricitabine (Truvada)for 7days in transgender women taking feminizing hormones

Group Type: EXPERIMENTAL

Tenofovir Disoproxil Fumarate/Emtricitabine

Intervention Type: DRUG

TFV/FTC dosing in Cis men

Single daily dose of oral Tenofovir Disoproxil Fumarate/Emtricitabine (Truvada) for 7days in cis men

Group Type: ACTIVE_COMPARATOR

Tenofovir Disoproxil Fumarate/Emtricitabine

Intervention Type: DRUG

Interventions

Tenofovir Disoproxil Fumarate/Emtricitabine

Intervention Type: DRUG

Other Intervention Names

Truvada

Eligibility Criteria

Inclusion Criteria

• TGW and cis men (male at birth and not a TGW)
• 18 to 65 years of age, inclusive on the date of screening
• Provides informed consent for the study
• Non-reactive HIV test results within four weeks of enrollment
• An estimated calculated creatinine clearance (eCcr) of at least 70 mL/min
• Agrees to use condoms for all sexual events during study participation.
• Taking daily oral Truvada® (Tenofovir disoproxil fumarate (TDF) 300 mg/Emtricitabine (FTC) 200 mg) for at least one week at the time of study PK sampling visit
• TGW have to be on an estradiol and have a serum total estradiol level > 100 picograms(pg)/ml

Exclusion Criteria

• Significant colorectal symptom(s) as determined by medical history or by participant self-report
• Participant-reported symptoms and/or clinical or laboratory diagnosis of active rectal infection requiring treatment per current Centers for Disease Control (CDC) guidelines
• A positive test for Herpes Simplex Virus -2 (HSV-2) (individuals with active lesions only)
• Co-enrollment in any other HIV interventional research study (excluding behavioral only interventions) or prior enrollment in the active arm of a HIV vaccine trial.
• Positive hepatitis B surface antigen (HBsAg) test
• Interleukin therapy; medications with significant nephrotoxic potential, including but not limited to amphotericin B, aminoglycosides, cidofovir, foscarnet and systemic chemotherapy; medications that may inhibit or compete for elimination via active renal tubular secretion (including but not limited to probenecid); systemic immunomodulatory medications
• Participants with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption
• Medications that prolong clotting time
• Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Hendrix, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University Drug Development Unit

Baltimore, Maryland, United States

Countries

United States

References

Shieh E, Marzinke MA, Fuchs EJ, Hamlin A, Bakshi R, Aung W, Breakey J, Poteat T, Brown T, Bumpus NN, Hendrix CW. Transgender women on oral HIV pre-exposure prophylaxis have significantly lower tenofovir and emtricitabine concentrations when also taking oestrogen when compared to cisgender men. J Int AIDS Soc. 2019 Nov;22(11):e25405. doi: 10.1002/jia2.25405.

Reference Type: DERIVED

PMID: 31692269 (View on PubMed)

Other Identifiers

IRB00092121

Identifier Type: -

Identifier Source: org_study_id