Safety and Pharmacokinetics of Oral Islatravir (MK-8591)... | NCT04003103

NCT04003103

ID	Type	Description	Link
Merck Protocol Number	Other Identifier	MK-8591-016
2019-001704-38	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Islatravir 60 mg	Experimental	60 mg islatravir + placebo for islatravir administered once monthly, orally in capsule form for 24 weeks	Drug: Islatravir Drug: Placebo
Islatravir 120 mg	Experimental	120 mg islatravir administered once monthly, orally in capsule form for 24 weeks	Drug: Islatravir
Placebo	Placebo Comparator	Placebo for islatravir administered once monthly, orally in capsule form for 24 weeks	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Islatravir	Drug	Islatravir 30 mg capsules taken by mouth.	Islatravir 120 mg Islatravir 60 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With ≥1 Adverse Event (AE) Through Week 36	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.	Up to 36 weeks
Number of Participants Discontinuing From Study Therapy Due to 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.	Up to 20 weeks
Number of Participants Discontinuing From Study Therapy Due to ≥1 Drug-related AE	A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered related to the study therapy.	Up to 20 weeks
Number of Participants With ≥1 Drug-related AE Through Week 36	A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered related to the study intervention.	Up to 36 weeks
Number of Participants With ≥1 Serious Adverse Event (SAE) Through Week 36	An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an other important medical event.	Up to 36 weeks
Number of Participants With a ≥1 Grade 3 to Grade 5 AE up to Week 36

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Plasma Concentration-time Curve From Dosing to 672 Hours Postdose (AUC0-672) of Plasma ISL	The AUC0-672 of ISL after dosing on Day 1 and Day 140 is reported. Only ISL-treated participants are included in the PK analysis.	Day 1 and Day 140: predose and 30-min postdose. On Day 2 collect ~24 hours after Day 1 dose. On Weeks 4, 8, 12 and 16, collect predose. Weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Centers of America, LLC ( Site 0007)		Hollywood	Florida	33024	United States
Johns Hopkins School of Medicine - Drug Development Unit ( Site 0002)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40327547	Result	Hillier SL, Bekker LG, Riddler SA, Hendrix CW, Badal-Faesen S, Macdonald P, Nair G, Lombaard J, Caraco Y, Peer A, Patel M, Vargo R, Homony B, Nedrow K, Evans B, Wickremasingha P, Zhou YP, Teal V, Hwang P, McMullan C, Kaufman KD, Robertson MN, Plank RM. Safety, Tolerability, and Pharmacokinetics of Once-Monthly Oral Islatravir: A Phase 2a Study in Participants at Low Risk for Acquiring Human Immunodeficiency Virus Type 1. J Infect Dis. 2025 Nov 14;232(5):1050-1060. doi: 10.1093/infdis/jiaf222.
41789892

Label	URL
Merck Clinical Trials Information	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
FG001	Islatravir 120 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 8, 2021	Feb 21, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
BG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
BG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00033.6± 9.9 BG00133.2± 9.7 BG00230.9± 7.9 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00066 BG00164 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00019 BG0019 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With ≥1 Adverse Event (AE) Through Week 36

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.

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 36 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Units	Counts
Participants	OG00097 OG00197 OG00248

Title

Denominators

Categories

Title	Measurements
	OG00066 OG00163 OG00236

Primary

Number of Participants Discontinuing From Study Therapy Due to 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.

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 20 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Primary

Number of Participants Discontinuing From Study Therapy Due to ≥1 Drug-related AE

A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered related to the study therapy.

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 20 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Primary

Number of Participants With ≥1 Drug-related AE Through Week 36

A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered related to the study intervention.

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 36 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Primary

Number of Participants With ≥1 Serious Adverse Event (SAE) Through Week 36

An SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an other important medical event.

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 36 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Primary

Number of Participants With a ≥1 Grade 3 to Grade 5 AE up to Week 36

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study therapy, whether or not considered related to the study intervention. Toxicity grading was according to the National Institutes of Health Division of AIDS (NIH DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events version 2.1 (Grade 3 is 'severe'; Grade 4 is 'potentially life-threatening'; and Grade 5 'results in death').

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 36 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Primary

Number of Participants With ≥1 Drug-related SAE Through Week 36

An drug-related SAE is defined as any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an other important medical event, that is considered related to study therapy.

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 36 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Primary

Number of Participants With ≥1 Drug-related Grade 3 to 5 AE Through Week 36

A drug-related Grade 3 to Grade 5 AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention; has a toxicity Grade 3 (severe), 4 (potentially life-threatening), or 5 (results in death); and is considered related to study therapy. Toxicity grading was according to the NIH DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (v. 2.1).

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 36 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Primary

Number of Participants With an AE Resulting in Death Through Week 36

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.

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 36 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Secondary

Area Under the Plasma Concentration-time Curve From Dosing to 672 Hours Postdose (AUC0-672) of Plasma ISL

The AUC0-672 of ISL after dosing on Day 1 and Day 140 is reported. Only ISL-treated participants are included in the PK analysis.

ISL-treated participants with data available who complied with the protocol sufficiently to ensure that generated data are likely to exhibit the effects of treatment, according to the underlying scientific model, are included.

Posted

Geometric Mean

Geometric Coefficient of Variation

hr*umol/L

Day 1 and Day 140: predose and 30-min postdose. On Day 2 collect ~24 hours after Day 1 dose. On Weeks 4, 8, 12 and 16, collect predose. Weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit.

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo

Secondary

Maximum Plasma Concentration (Cmax) of ISL

The Cmax of ISL after dosing on Day 1 and Day 140 is reported. Only ISL-treated participants are included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

µmol/L

Day 1 and Week 20, collect predose and 30-min postdose. On Day 2 collect ~24 hours after Day 1 dose. On Weeks 4, 8, 12 and 16, collect predose. Weeks 1, 2, 3, 21, 22, 23 and 24: collect at any time during the study visit.

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Secondary

Trough Plasma Concentration (Ctrough) of ISL

The plasma Ctrough of ISL after dosing on Day 1 and Day 140 is reported. Only ISL-treated participants are included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

µmol/L

Day 1 and Week 20: predose and 30-min postdose. Day 2: 24 hours post Day 1 dose. Weeks 1, 2, 3, 21, 22, 23 and 24: any time during the study visit. Weeks 4, 8, 12 and 16: predose.

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Secondary

Apparent Plasma Terminal Half-life (t1/2) of ISL

The plasma t1/2 of ISL after dosing on Day 140 is reported. Only ISL-treated participants are included in the PK analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Secondary

Number of Participants With ≥1 AE Through Week 24

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.

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 24 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Secondary

Number of Participants With ≥1 Drug-related AE Through Week 24

A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered related to the study intervention.

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 24 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Secondary

Number of Participants With ≥1 SAE Through Week 24

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 24 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Secondary

Number of Participants With a ≥1 Grade 3 to Grade 5 AE up to Week 24

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 24 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Secondary

Number of Participants With ≥1 Drug-related SAE Through Week 24

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 24 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Secondary

Number of Participants With ≥1 Drug-related Grade 3 to 5 AE Through Week 24

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 24 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Secondary

Number of Participants With an AE Resulting in Death Through Week 24

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.

All participants who received ≥1 dose of study therapy are included.

Posted

Count of Participants

Participants

Up to 24 weeks

ID	Title	Description
OG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.
OG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Islatravir 60 mg	Participants receive two ISL 30 mg capsules + two ISL placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.	1	97	1	97	24	97
EG001	Islatravir 120 mg	Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.	0	97	0	97	23	97
EG002	Placebo	Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.	0	48	0	48	16	48

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Intentional self-injury	Psychiatric disorders	MedDRA 25.0	Systematic Assessment		EG0001 affected97 at risk EG0010 affected97 at risk EG0020 affected48 at risk
Loss of consciousness	Nervous system disorders	MedDRA 25.0	Systematic Assessment		EG0001 affected97 at risk EG0010 affected97 at risk EG0020 affected48 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected97 at risk EG0013 events3 affected97 at risk EG0024 events4 affected48 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0005 events5 affected97 at risk EG0015 events4 affected97 at risk EG0024 events4 affected48 at risk
Nausea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0006 events5 affected97 at risk EG0017 events7 affected97 at risk EG0022 events2 affected48 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0005 events4 affected97 at risk EG0014 events4 affected97 at risk EG0024 events3 affected48 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected97 at risk EG0011 events1 affected97 at risk EG0023 events3 affected48 at risk
Alanine aminotransferase increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected97 at risk EG0010 events0 affected97 at risk EG0023 events3 affected48 at risk
Blood pressure increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected97 at risk EG0015 events5 affected97 at risk EG0020 events0 affected48 at risk
Dizziness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected97 at risk EG0010 events0 affected97 at risk EG0024 events3 affected48 at risk
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG00027 events10 affected97 at risk EG0019 events9 affected97 at risk EG0022 events2 affected48 at risk

ID	Term
C558823	islatravir

Units	Counts
Participants	OG00097 OG00197 OG00248

Units	Counts
Participants	OG00097 OG00197 OG00248

Units	Counts
Participants	OG00097 OG00197 OG00248

Units	Counts
Participants	OG00097 OG00197 OG00248

Participants receive four placebo capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.

Units	Counts
Participants	OG00097 OG00197 OG00248

Units	Counts
Participants	OG00097 OG00197 OG00248

Units	Counts
Participants	OG00097 OG00197 OG00248

OG0010.000124± 42.0