Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis

STUDY BASICS

This research study is testing a PrEP drug, MK-8527, in people who could be exposed to HIV-1. The purpose of this trial is to test the safety of the trial drug, MK-8527 compared to emtricitabine/tenofovir (FTC/TDF) and to also see how well MK-8527 works to reduce the chance of getting HIV-1 infection compared to FTC/TDF. Study participation involves about one visit/month over 3 years.

STUDY PURPOSE

This research study is testing a PrEP drug, MK-8527, in people who could be exposed to HIV-1. The purpose of this trial is to test the safety of the trial drug, MK-8527 compared to emtricitabine/tenofovir (FTC/TDF) and to also see how well MK-8527 works to reduce the chance of getting HIV-1 infection compared to FTC/TDF.

COULD THIS STUDY BE RIGHT FOR YOU?

You may be able to join this trial at UPMC if you identify as: 

• Cisgender man (assigned male at birth and identify as male) 

• Transgender woman (assigned male at birth and identify as female) 

• Transgender man (assigned female at birth and identify as male)  

• Gender nonbinary (assigned any gender at birth and do not identify as exclusively male or female) 

And: 

• Do not have HIV  

• Are at least 18 years old 

Even if you meet these basic requirements, there may be reasons why you cannot be in this trial. The trial doctor or trial staff will discuss this with you. 

WHAT PARTICIPANTS CAN EXPECT

This trial has 2 groups. If you participate, the study drug you get will depend on which group you are placed in.  A computer will decide which group you are put in.  You have an equal chance of being put in either group.  You will not know which group you were assigned. 

· Group 1: will get MK-8527 once a month plus FTC/TDF placebo once a day

· Group 2: will get FTC/TDF once a day plus MK-8527 placebo once a month

Participants will come to the clinic for scheduled visits about 36 times over approximately 3 years (once a month).