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

HIV Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060785
• Other study ID #: IRB00092121
• Status: Completed
• Phase: Phase 1
• Start date: March 8, 2016
• Est. completion date: May 31, 2018

Study information

• Verified date: July 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Drug:
• Tenofovir Disoproxil Fumarate/Emtricitabine

Locations

Country	Name	City	State
United States	Johns Hopkins University Drug Development Unit	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colon tissue tenofovir diphosphate (TFV-DP)	Endoscopy will be performed to obtain colorectal tissue biopsies. 15 biopsies will be collected and processed to isolate mucosal mononuclear cells (MMC). TFV-DP will be measured and reported as femtomoles per million cells (fmole/10E6 cells).	One week
Secondary	Ex vivo colon explant HIV challenge	Colorectal tissue biopsies will be collected and exposed ex vivo to HIV and kept in culture for 15 days. Every three days a sample of fluid bathing the tissue sample will be tested for HIV p24 antigen. Results will be reported as picograms of p24 per milliliter (pg/mL).	One week