Brief Summary
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
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
Brief Title
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-888-577-8839
Central Contact Email
Trialsites@msd.com
Completion Date
Completion Date Type
Estimated
Conditions
Human Immunodeficiency Virus (HIV)
HIV Pre-Exposure Prophylaxis
Eligibility Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* 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
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* 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
* Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration
* Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1
* Is expecting to donate eggs at any time during the study
The main inclusion criteria include but are not limited to the following:
* 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
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* 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
* Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration
* Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1
* Is expecting to donate eggs at any time during the study
Inclusion Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* 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
The main inclusion criteria include but are not limited to the following:
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
16 Years
NCT Id
NCT07044297
Org Class
Industry
Org Full Name
Merck Sharp & Dohme LLC
Org Study Id
8527-011
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
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
Primary Outcomes
Outcome Description
The number of participants with adjudicated HIV-1 infection will be determined.
Outcome Measure
Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Outcome Time Frame
Up to approximately 2 years
Outcome Description
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.
Outcome Measure
Number of Participants Who Experience At Least One Adverse Event (AE)
Outcome Time Frame
Up to approximately 2 years
Outcome Description
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.
Outcome Measure
Number of Participants Who Discontinue Study Intervention Due to an AE
Outcome Time Frame
Up to approximately 2 years
Secondary Ids
Secondary Id
MK-8527-011
Secondary Id
2025-520610-58-00
Secondary Id
U1111-1317-6239
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
16
Investigators
Investigator Type
Principal Investigator
Investigator Name
Barry Zingman
Investigator Email
bzingman@montefiore.org
Investigator Phone
718-920-2647
Investigator Department
Medicine
Investigator Division
Infectious Diseases
Investigator Sponsor Organization
External
Study Department
Medicine
Study Division
Infectious Diseases
Categories Mesh Debug
Kaposi Sarcoma & AIDS-Related Cancers --- ACQUIRED IMMUNODEFICIENCY SYNDROME
HIV/AIDS --- ACQUIRED IMMUNODEFICIENCY SYNDROME
Kaposi Sarcoma & AIDS-Related Cancers --- HIV INFECTIONS
HIV/AIDS --- HIV INFECTIONS
Infectious Disease --- HIV INFECTIONS
Blood Disorders --- BLOOD-BORNE INFECTIONS
HIV/AIDS --- BLOOD-BORNE INFECTIONS
Infectious Disease --- BLOOD-BORNE INFECTIONS
Hepatitis --- COMMUNICABLE DISEASES
HIV/AIDS --- COMMUNICABLE DISEASES
Infectious Disease --- COMMUNICABLE DISEASES
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
HIV/AIDS --- SEXUALLY TRANSMITTED DISEASES, VIRAL
Infectious Disease --- SEXUALLY TRANSMITTED DISEASES, VIRAL
HIV/AIDS --- SEXUALLY TRANSMITTED DISEASES
Infectious Disease --- SEXUALLY TRANSMITTED DISEASES
Infectious Disease --- LENTIVIRUS INFECTIONS
Infectious Disease --- RETROVIRIDAE INFECTIONS
COVID-19 --- RNA VIRUS INFECTIONS
Infectious Disease --- RNA VIRUS INFECTIONS
COVID-19 --- VIRUS DISEASES
Hepatitis --- VIRUS DISEASES
Infectious Disease --- VIRUS DISEASES
Infectious Disease --- IMMUNOLOGIC DEFICIENCY SYNDROMES
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
ACQUIRED IMMUNODEFICIENCY SYNDROME
HIV INFECTIONS
BLOOD-BORNE INFECTIONS
COMMUNICABLE DISEASES
INFECTIONS
SEXUALLY TRANSMITTED DISEASES, VIRAL
SEXUALLY TRANSMITTED DISEASES
LENTIVIRUS INFECTIONS
RETROVIRIDAE INFECTIONS
RNA VIRUS INFECTIONS
VIRUS DISEASES
SLOW VIRUS DISEASES
GENITAL DISEASES
UROGENITAL DISEASES
IMMUNOLOGIC DEFICIENCY SYNDROMES
IMMUNE SYSTEM DISEASES
EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE DRUG COMBINATION
TENOFOVIR
ORGANOPHOSPHONATES
ORGANOPHOSPHORUS COMPOUNDS
ORGANIC CHEMICALS
EMTRICITABINE
DEOXYCYTIDINE
CYTIDINE
PYRIMIDINE NUCLEOSIDES
PYRIMIDINES
HETEROCYCLIC COMPOUNDS, 1-RING
HETEROCYCLIC COMPOUNDS
ADENINE
PURINES
HETEROCYCLIC COMPOUNDS, 2-RING
HETEROCYCLIC COMPOUNDS, FUSED-RING
DEOXYRIBONUCLEOSIDES
NUCLEOSIDES
NUCLEIC ACIDS, NUCLEOTIDES, AND NUCLEOSIDES
DRUG COMBINATIONS
PHARMACEUTICAL PREPARATIONS