Emtricitabine/Tenofovir Alafenamide Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate Pre-Exposure Prophylaxis (PrEP) levels in transgender-identifying or gender non-binary individuals taking versus not taking gender affirming hormone therapy. Subjects who have previously taken F/TDF as PrEP will continue with a fixed dose combination of daily oral F/TAF substituting for F/TDF. Subjects will receive the iTAB text messaging adherence reminders to provide personalized, automated text messages to support and monitor adherence that will vary by participant choice until 12 weeks after switching medication. This study will enroll 60 individuals to take F/TAF as PrEP for 48 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Emtricitabine; Emtricitabine tenofovir alafenamide; Tenofovir

Criteria

Inclusion Criteria:

1. Transgender or non-binary, defined as identifying with a gender differently from sex assigned at birth

2. Age 18 years or older

3. Currently eligible to take F/TDF for PrEP and willing to switch to F/TAF

4. Negative for HIV infection

5. Acceptable renal function as measured by calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula in the past 30 days

Exclusion Criteria:

1. Unable to give informed consent

2. Active hepatitis B defined by a positive hepatitis B surface antigen (HBsAg)

3. Substantial medical condition that, in the opinion of the investigator, would preclude participation, as defined by

• gastrointestinal condition that would impair absorption of study drugs

• known condition of reduced bone density (e.g. osteoporosis or osteogenesis imperfect) that significantly elevate the risk of bone fracture

• neurological or severe psychiatric condition that would significantly impair the ability to adhere to PrEP

• tubular or glomerular kidney disease that could be exacerbated by tenofovir

• other medical condition that would unacceptably increase the risk of harm from study drug or significantly impair the ability to adhere to PrEP

4. Suspected sensitivity or allergy to the study drug or any of its components

5. Currently using an essential product or medication that interacts with the study drug such as the following:

• other antiretroviral agent other than F/TDF (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, integrase inhibitors, protease inhibitors or investigational antiretroviral agents)

• agents with known nephrotoxic potential:

• aminoglycoside antibiotics (including gentamicin)

• IV amphotericin B

• cidofovir

• cisplatin

• foscarnet

• IV pentamidine

• IV vancomycin

• oral or IV gancyclovir

• other agents with significant nephrotoxic potential

• drugs that slow renal excretion

• probenecid

• immune system modulators

• systemic chemotherapeutic agents (i.e. cancer treatment medications)

• ongoing systemic corticosteroids (with the exception of short courses of tapering steroid doses for asthma or other self- limited condition).

• interleukin-2 (IL-2)

• interferon (alpha, beta, or gamma)

• other agent known to have a significant interaction with TDF, TAF, or FTC

• the following table includes medications/herbal supplements to be excluded or should be used with caution while participants are taking study drugs due to potential drug-drug interactions with F/TAF.

6. Proteinuria 2+ or greater by urine dipstick

7. Pregnancy (if applicable)

8. Other condition that, in the opinion of the investigator, would put the participant at risk, complicate interpretation of study outcome data, or would otherwise interfere with participation or achieving the study objectives