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EXPRESSIVE11: MK-8527 for HIV Prevention

About this study

Many people around the world still get HIV, a virus that harms and changes certain cells of the body’s immune system. There is a strong need for easier ways to prevent HIV. 

MK-8527 is a new pill that might help prevent HIV when taken once a month. Right now, prevention pills must be taken every day. A monthly pill could make it much easier for people to stay protected from HIV and reduce new HIV infections worldwide.

In this study, researchers will compare once-a-month MK-8527 to once-a-day emtricitabine/tenofovir (FTC/TDF). FTC/TDF is a pill that is already approved for HIV prevention and must be taken every day. Both medicines are taken by mouth.

People in this study will be placed into 1 of 2 groups. A computer will randomly assign people to a group so the study is fair.

  • Group 1: Will take the pill MK-8527 once a month and a placebo pill every day. A placebo is a pill that looks like real medicine but has no active form of the medicine in it. 
  • Group 2: Will take the approved FTC/TDF every day and a placebo pill once a month

Everyone will visit the clinic about once a month for HIV testing and counseling. Participants will be checked for side effects and HIV status at every visit. The study will last about two and a half years. After that time, participants will stop getting the trial drugs assigned to them and will start getting FTC/TDF. They will take FTC/TDF for about 28 days.

People should not assume they are protected from HIV or other sexually transmitted infections while in the study. They need to keep using normal steps to stay safe. If they are not sure how, they can ask the study doctor or staff for help.

The main goal is to see if MK-8527 works as well as FTC/TDF to prevent HIV. Researchers will also look at safety and side effects. 

Researchers need to find out if taking MK-8527 once a month is safe and works to prevent HIV. If it works, this new option could make HIV prevention easier and help more people stay protected.

Eligibility overview

  • Cisgender man, transgender woman, transgender man, or gender nonbinary
  • Age 16 years and older
  • Does not have HIV
  • Not currently taking other HIV prevention medicines

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

EXPRESSIVE11: A Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-monthly as HIV-1 Preexposure Prophylaxis

Study goal:

To study MK-8527 and compare it to emtricitabine/tenofovir (FTC/TDF) for HIV-1 prevention

Diagnosis:

HIV-1 infection prevention

Age:

16 years and older

Clinical trial categories:

Human Immunodeficiency Virus (HIV) Infection Infectious Diseases

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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