Active not recruitingPHASE3INTERVENTIONAL

Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

This research study is investigating a new daily tablet called F/TAF, designed to prevent HIV infection. It's for men and transgender women who have sex with men and are considered at elevated risk of catching HIV. The study's main goal is to see how effective and safe this new tablet is compared to an already approved HIV prevention tablet called F/TDF. Participants will take one of these tablets or a dummy pill (placebo) every day. We will follow them closely for nearly a year, or even longer for some, to track how many people get HIV and if there are any side effects. This is a "Phase 3" study, which means it's one of the final steps before a new treatment might be made available to everyone.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Gilead Sciences

Enrolment target

5,399

Start

02 Sep 2016

Estimated completion

01 Jul 2026

Pre-Exposure Prophylaxis of HIV-1 Infection

Results

Results from this study

Posted March 2020

Results have been published for this study.

Primary outcome

Incidence of HIV-1 Infection Per 100 Person Years (PY)

The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study. HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab: * Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or * Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or * Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)

Full results on the registry

What is this study about?

This study is looking into a new tablet called F/TAF, which is designed to help prevent HIV infection. You might have heard of "PrEP," which stands for Pre-Exposure Prophylaxis. This means taking medication *before* you might be exposed to HIV to significantly reduce your risk of getting the virus. This study is specifically for men and transgender women who have sex with men and are at a higher risk of HIV infection.

The main aim is to see how well this new F/TAF tablet works compared to a similar, already approved tablet called F/TDF. We want to know if F/TAF is as effective, or even more effective, at preventing HIV. We also want to check if it's safe to use and if people experience any side effects. This is a "Phase 3" study, which means it's a large, important step in testing a new medication before it can be made available more widely.

Participants will be given one of the actual prevention tablets (F/TAF or F/TDF) or a placebo (a dummy pill with no active medicine) to take every day. We will then carefully monitor them for at least 48 weeks (about 11 months), and for many participants, even longer, up to 96 weeks (about 22 months). This long follow-up allows us to get a clear picture of how well the tablets work over time and to identify any long-term effects. The results of this study will help doctors and patients make informed decisions about HIV prevention.

Key takeaways

This study evaluates a new HIV prevention tablet (F/TAF) for men and transgender women who have sex with men.
It compares F/TAF to an existing prevention tablet (F/TDF) and dummy pills (placebo).
Participation involves taking a daily tablet and regular health checks for up to 22 months.
The study aims to understand how well F/TAF works and if it is safe.
You must not have HIV to join this study.

Who may be eligible?

To join this study, you must be at least 18 years old. You must be a man or a transgender woman who was assigned male at birth and who has sex with men. It's very important that you do *not* have HIV when you start the study.

We're looking for individuals who are at a high risk of getting HIV through sex. This might include if you've had unprotected anal sex with at least two different male partners in the last 12 weeks, especially if their HIV status was unknown or if they were HIV positive. It also includes if you've had syphilis, or a rectal gonorrhea or chlamydia infection in the past six months.

You'll also need to be in good general health, which includes your kidneys, liver, and blood. We'll do some tests to make sure these are working well before you can join. There are a few reasons someone might not be able to join, for example, if you have certain kidney problems that are not explained or cannot be easily managed. Your doctor will discuss all the specific criteria with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you a man or a transgender woman who has sex with men?
Do you *not* currently have HIV?
Are you considered at high risk for getting HIV (e.g., specific sexual activity or recent STIs)?
Are your kidneys, liver, and blood generally healthy?
Do you understand the commitment of regular study visits for up to 22 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance (like flipping a coin) to one of four groups. You will either receive the new F/TAF tablet, the existing F/TDF tablet, or a 'dummy' tablet (a placebo) for either F/TAF or F/TDF. You will take one tablet every day.

You will have regular study visits, which will include health checks, blood tests, and discussions about how you're feeling and any side effects you might be having. These visits will also include tests to make sure you haven't gotten HIV. Initially, these visits might be more frequent, then they will become less often. The study will last for at least 48 weeks (about 11 months), and for many participants, it will be up to 96 weeks (about 22 months). During this time, you'll be giving information about your sexual health and any changes you notice.

Potential risks and benefits

Potential benefits of taking part include contributing to important research that could help prevent HIV infection for many people in the future. You will also receive careful medical monitoring throughout the study. However, there's no guarantee that you will personally benefit, as you might receive a placebo or the medication might not completely prevent HIV in your case. Potential risks could include side effects from the medication, which will be carefully monitored. You'll also need to attend regular clinic visits and have blood tests. Importantly, you have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (93)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Beverly Hills, United States
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Los Angeles, United States
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Los Angeles, United States
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Newport Beach, United States
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Oakland, United States
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Sacramento, United States
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Sacramento, United States
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San Diego, United States
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San Francisco, United States
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San Francisco, United States
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San Francisco, United States
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Torrance, United States

Common questions

What is HIV Pre-Exposure Prophylaxis (PrEP)?

PrEP means taking medication *before* possible exposure to HIV to greatly reduce your risk of getting the virus.

What is the difference between F/TAF and F/TDF?

F/TAF is a new tablet being tested, and F/TDF is an existing, approved tablet for HIV prevention. Both contain similar active ingredients but might have different effects on the body.

Will I know if I'm getting a 'dummy' pill (placebo)?

No, this is a 'blinded' study, meaning neither you nor the study team will know if you're taking the active drug or a placebo until the study ends. This helps ensure fair results.

How long will I be in the study?

You will be in the study for at least 48 weeks (about 11 months), and some participants will continue for up to 96 weeks (about 22 months).

What if I get HIV while in the study?

If you get HIV during the study, the study team will stop the prevention medication and refer you for appropriate HIV care and treatment.