Learn about a clinical research study testing an investigational monthly PrEP (pre-exposure prophylaxis) medicine.
The EXPrESSIVE-011 Clinical Research StudyClinical Study / Clinical TrialA research study designed to learn how our bodies respond to medicines, vaccines or other treatments; A way to study new medicines (vaccines), devices and treatments to see if they are safe and work in people; Compares a study treatment to another treatment or even no treatment (placebo) is testing an investigational medicineInvestigational Medicine (Treatment)A treatment or medicine in a clinical study which is not yet approved [by health authorities or government agencies] for the condition being studied, which is a type of PrEP (pre-exposure prophylaxis).ProphylaxisMedicine, or action taken to help prevent a specific condition or illness PrEP is a medicineDrug (or medicine, medication, treatment)Medicine being studied in the clinical trial; study medication; study treatment. that may help lower the chance of becoming infectedInfectionIllness caused by germs; when germs get into the body and cause illness with human immunodeficiency virus (HIV)Human Immunodeficiency Virus (HIV)A virus that attacks cells of the immune system in people at risk of being exposed to the virusVirusVery small germs that need to be in a person to multiply and survive; germs that can cause infection that can’t be treated with antibiotics. A PrEP medicine is taken before being exposed to HIV to help lower the chances of being infected by HIV.
This study is comparing the investigational medicine to an approved PrEP medicine to evaluate the investigational medication’s safety, how it works in the body, as well as any side effectsSide effectAn effect of a medicine, treatment or intervention that is additional to the main intended effect and can be good, bad or neutral; A health problem that is likely caused by an approved treatment.
NATIONAL TRIAL REFERENCE NUMBER
NCT07044297
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
You will be randomlyRandomize/RandomizationAssignment by chance to receive, or not, the treatment being studied; the process by which people in clinical trials are assigned (by chance) to separate groups; A way to use chance to place study participants into different study treatment groups; helps to make sure study groups can be compared against each other at the end of the study to avoid bias assigned to 1 of 2 groups, similar to flipping a coin, giving you a 50/50 chance of receiving 1 of the following:
The placeboPlaceboA placebo looks like the study medicine but has no study medicine/treatment in it. Using a placebo helps researchers better understand the effects of the study medicine/treatment. tablets look like either the investigational medicine or the PrEP medication, but do not contain any active ingredients. Researchers use placebos to better understand the effects of the investigational medicine. ParticipantsParticipantPerson; people in a clinical trial., the study doctorPrincipal Investigator, study physicianStudy doctor (scientist, or other health professional) who is responsible for making sure the study is carried out as planned; a person who leads the research study at a study site., and the study team will not know which group each participant is placed in.
Your doctor is your best resource for deciding if a study is right for you, but your personal support team can also help you along the way.
You may be able to take part in the EXPrESSIVE-011 Clinical Research Study if you are at least 16 years of age and:
There are additional eligibility criteriaEligibility criteriaA set of requirements (characteristics) used to determine whether a person can enroll in a study [clinical trial]; the reasons a person can be included in, or excluded from a study; used to make sure that a study includes the right participants to help answer the research questions [For example, a study may be looking to include only people of a certain age or with a certain health condition. When all participants meet the same eligibility criteria, it is more likely that results of the study are caused by the intervention being tested and not by other factors or by chance]; See also Inclusion Criteria, Exclusion Criteria, which the study team can discuss with you. There may be risksRiskChance (likelihood) for an event, reaction or health problem to happen related to participating in this clinical research study.
The study lasts for up to 30 months (around 2.5 years), and you will have monthly study clinic visits. How long you are in the study depends on when you
start the study.
Before joining this study, you will have a screening visit to find out if you are eligible to join. If you can and want to join the study, you will read and sign an informed consent form (ICF)Informed Consent form (IC)A document that provides information about the purpose of the study, possible risks and benefits, and the participant's rights and responsibilities. Signing the consent form means that the person agrees to participate in the research; A document used to explain the details of a study (clinical trial). If you are under 18, your parents/guardian will sign the ICF, and you will sign an assent form. The ICF gives you details about the study, including the medical tests you can expect and the possible risks and benefits of participating.
Length of study: Up to 30 months (around 2.5 years)
Study design: About 4390 participants will be randomly assigned to 1 of 2 groups:
(up to 45 days)
At least 1 study visit for medical tests to determine eligibility to be in this study
(about 2.5 years)
Monthly visits for medical tests and exams including physical exams, urine (pee) tests, throat and rectal swabs, blood draws, pregnancy tests (if you are able to get pregnant), and completion of surveys
(about 2 months)
After you stop taking your assigned study medicine, you will enter the follow-up period. You will visit the study site up to 2 times and have 1 phone call visit. For the first 28 days of follow-up, all participants will take the daily comparator PrEP medicine
PrEP is a type of medicine that may help lower the chance of becoming infected with human immunodeficiency virus (HIV) in people at risk of being exposed to the virus. PrEP does not protect against other sexually transmitted infections (STIs) or diseases.
The EXPrESSIVE-011 Clinical Research Study is a phase 3, randomized, active controlledActive controlA group of people in a clinical study who get an approved (standard) treatment for the condition being studied; See also Active Comparator arm, double-blindDouble-blindA type of study when the participants and researchers do not know which treatment participants are receiving [Some studies are done this way because knowing what treatment each participant is getting can affect the way the results are seen/viewed.] clinical study to evaluate the efficacyEfficacyIn a clinical study- How well a treatment, medicine, or vaccine works to treat or prevent a condition and safetySafe / SafetyAn assessment of the likelihood of causing an undesired effect of MK 8527 oral once monthly as HIV-1 pre-exposure prophylaxis.
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest study site. Talk with a study site member for more information.
Researchers are testing an investigational medicine, which is a type of PrEP (pre-exposure prophylaxis). The goal is to compare the investigational medicine to an approved PrEP medicine to assess the investigational medicine’s safety, how it functions in the body, and any side effects (tolerability).Tolerability[A measurement of] How well people manage or handle the effects of a medicine, treatment, or vaccine
Before you agree to participate, the study team will review all aspects of the clinical study with you. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the clinical study’s purpose, assessments, procedures, potential benefits and risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.
A placebo is a material that looks like the investigational medicine but does not contain any active medication. Using a placebo helps researchers better understand the effects of the study medicine/treatment. In this clinical study, all participants will take 2 tablets, 1 active medication (either the investigational medicine or another approved PrEP medicine) AND 1 placebo.
The study team respects and protects your privacy and will not share your information, except as required by law, and will store your personal information with codes that do not identify you. The Informed Consent Form (completed by you prior to participation) will provide more information about how your privacy will be maintained.
Your participation in the clinical study is entirely voluntary and you may withdraw for any reason, at any time. If you do decide to withdraw early, you will be asked to notify the study team before doing so. You will be asked to return to the study site at least once to complete a final visit and return any unused study medicine
No, you will receive the investigational medicine at no cost. You will also get all study-related medical tests at no cost.
No, your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up to date about your progress.
A clinical study tries to answer questions about how medicines work in the people who take them. Researchers run studies to test whether an investigational medicine is safe and effective. These studies may help doctors find new ways to help prevent, detect, or treat health problems.
Participant safety is the priority. There are rules in place to help protect the rights, safety, and well-being of people who volunteer for clinical studies. These rules are put in place to make sure clinical studies follow strict scientific and ethical guidelines.
Before a clinical study can begin, a review board or ethics committee must review the clinical study. In the U.S., this group is called an IRB or Institutional Review BoardInstitutional Review Board (IRB)(In US): A team of people who review studies to protect the rights and welfare of study participants; A group formally designated and responsible for reviewing study proposals, monitoring studies involving people and protecting the rights and welfare of study participants. An IRB is made up of doctors, scientists, and other members of the community.
Only people who meet all eligibility criteria for a clinical study may take part. The study team at the site you select will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate. You may also be asked to provide information from your medical records to help the study team determine whether you may be eligible.
An investigational medicine is a drug that hasn’t yet been approved for use in the general public. In order for it to be approved, the investigational medicine must be tested in clinical studies to see if it is safe and effective for treating the target disease in certain groups of people.
The investigational medicine in the EXPrESSIVE-011 Clinical Research Study is being tested to see how well it may work to prevent HIV compared to an approved PrEP medicine.
If you are eligible and choose to participate, the study staff will be available to answer any questions you may have.
For more answers to your questions, visit: https://merckclinicaltrials.com/faq/
If you think this clinical study might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
Print this page with details about the study or email it to your doctor to discuss the clinical trial during your next visit.
Get help talking with your doctor or care team
NATIONAL TRIAL REFERENCE NUMBER
NCT07044297
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
If you are considering joining a clinical study, it is important to learn as much as you can about:
Talk to your doctor about the clinical study before you decide to join.
Read our “What to Consider” page for more things to think about and questions to ask
