A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16+
SponsorMerck Sharp & Dohme LLC
About this trial
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.
The goals of this study are to learn:
* If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person
Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening
Weighs ≥35 kg
Disqualifiers
Has hypersensitivity or other contraindication to any component of the study interventions
Has evidence of acute or chronic hepatitis B infection
Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers
Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
Trial design
Design model
Parallel
Treatments tested in this trial
MK-8527
DrugOral tablet
FTC/TDF
DrugOral tablet
Placebo to MK-8527
DrugPlacebo tablet matched to MK-8527
Placebo to FTC/TDF
DrugPlacebo tablet matched to FTC/TDF
Treatment groups
4,390 Participants
are divided into 2 treatment groupsGroup A: MK-8527Experimental treatment 3 interventions
Group B: FTC/TDFActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection
The number of participants with adjudicated HIV-1 infection will be determined.
Time frame
Up to approximately 2 years2
Number of Participants Who Experience At Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experienced AEs will be reported.
Time frame
Up to approximately 2 years3
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinued study intervention due to an AE will be reported.
Time frame
Up to approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov