Trial Outcomes & Findings for Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007) (NCT NCT06045507)

Last Updated: 2026-01-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

352 participants

Primary outcome timeframe

Up to ~28 weeks

Results posted on

2026-01-07

Participant Flow

Adult participants who were at low risk of human immunodeficiency virus Type 1 (HIV-1) infection were recruited.

Participant milestones

Participant milestones
Measure	MK-8527 3 mg QM Participants received oral MK-8527 3 mg once monthly (QM) for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 6 mg QM Participants received oral MK-8527 6 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 12 mg QM Participants received oral MK-8527 12 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	Placebo to MK-8527 Participants received oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
Overall Study STARTED	101	102	100	49
Overall Study COMPLETED	92	97	98	46
Overall Study NOT COMPLETED	9	5	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-8527 3 mg QM Participants received oral MK-8527 3 mg once monthly (QM) for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 6 mg QM Participants received oral MK-8527 6 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 12 mg QM Participants received oral MK-8527 12 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	Placebo to MK-8527 Participants received oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
Overall Study Death	0	0	1	0
Overall Study Lost to Follow-up	3	3	0	0
Overall Study Randomized by mistake (no study treatment given)	0	1	1	0
Overall Study Withdrawal by Subject	4	1	0	2
Overall Study Miscellaneous	2	0	0	1

Baseline Characteristics

Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-8527 3 mg QM n=101 Participants Participants received oral MK-8527 3 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 6 mg QM n=101 Participants Participants received oral MK-8527 6 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 12 mg QM n=99 Participants Participants received oral MK-8527 12 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	Placebo to MK-8527 n=49 Participants Participants received oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.	Total n=350 Participants Total of all reporting groups
Sex: Female, Male Male	43 Participants n=37 Participants	42 Participants n=56 Participants	41 Participants n=95 Participants	20 Participants n=61 Participants	146 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=37 Participants	13 Participants n=56 Participants	14 Participants n=95 Participants	11 Participants n=61 Participants	56 Participants n=5 Participants
Age, Continuous	30.4 Years STANDARD_DEVIATION 10.12 • n=37 Participants	30.0 Years STANDARD_DEVIATION 9.80 • n=56 Participants	29.6 Years STANDARD_DEVIATION 8.84 • n=95 Participants	29.8 Years STANDARD_DEVIATION 8.90 • n=61 Participants	30.0 Years STANDARD_DEVIATION 9.48 • n=5 Participants
Sex: Female, Male Female	58 Participants n=37 Participants	59 Participants n=56 Participants	58 Participants n=95 Participants	29 Participants n=61 Participants	204 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=37 Participants	86 Participants n=56 Participants	84 Participants n=95 Participants	38 Participants n=61 Participants	291 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	2 Participants n=56 Participants	1 Participants n=95 Participants	0 Participants n=61 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants	0 Participants n=61 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=37 Participants	2 Participants n=56 Participants	3 Participants n=95 Participants	0 Participants n=61 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants	0 Participants n=61 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	44 Participants n=37 Participants	40 Participants n=56 Participants	40 Participants n=95 Participants	21 Participants n=61 Participants	145 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=37 Participants	54 Participants n=56 Participants	51 Participants n=95 Participants	26 Participants n=61 Participants	180 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants	0 Participants n=61 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=37 Participants	5 Participants n=56 Participants	5 Participants n=95 Participants	2 Participants n=61 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to ~28 weeks

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

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.

Outcome measures

Outcome measures
Measure	MK-8527 3 mg QM n=101 Participants Participants received oral MK-8527 3 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 6 mg QM n=101 Participants Participants received oral MK-8527 6 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 12 mg QM n=99 Participants Participants received oral MK-8527 12 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	Placebo to MK-8527 n=49 Participants Participants received oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
Number of Participants With ≥1 Adverse Event (AE)	62 Participants	69 Participants	66 Participants	31 Participants

PRIMARY outcome

Timeframe: Up to ~20 weeks

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

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.

Outcome measures

Outcome measures
Measure	MK-8527 3 mg QM n=101 Participants Participants received oral MK-8527 3 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 6 mg QM n=101 Participants Participants received oral MK-8527 6 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 12 mg QM n=99 Participants Participants received oral MK-8527 12 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	Placebo to MK-8527 n=49 Participants Participants received oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
Number of Participants Discontinuing Study Therapy Due to Adverse Event (AE)	0 Participants	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose

Population: Participants treated with active MK-8527 who complied with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model, are included.

The plasma AUC0-last of MK-8527 is reported.

Outcome measures

Outcome measures
Measure	MK-8527 3 mg QM n=95 Participants Participants received oral MK-8527 3 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 6 mg QM n=96 Participants Participants received oral MK-8527 6 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 12 mg QM n=97 Participants Participants received oral MK-8527 12 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	Placebo to MK-8527 Participants received oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527 Week 20	0.129 hr*µmol/L Geometric Coefficient of Variation 81.5	0.404 hr*µmol/L Geometric Coefficient of Variation 37.3	0.836 hr*µmol/L Geometric Coefficient of Variation 55.0	—
Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527 Day 1	0.132 hr*µmol/L Geometric Coefficient of Variation 84.8	0.397 hr*µmol/L Geometric Coefficient of Variation 36.1	0.861 hr*µmol/L Geometric Coefficient of Variation 34.1	—

SECONDARY outcome

Timeframe: Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose

The plasma Cmax of MK-8527 is reported.

Outcome measures

Outcome measures
Measure	MK-8527 3 mg QM n=95 Participants Participants received oral MK-8527 3 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 6 mg QM n=96 Participants Participants received oral MK-8527 6 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 12 mg QM n=97 Participants Participants received oral MK-8527 12 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	Placebo to MK-8527 Participants received oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
Maximum Plasma Concentration (Cmax) of MK-8527 Day 1	0.0289 µmol/L Geometric Coefficient of Variation 69.0	0.0490 µmol/L Geometric Coefficient of Variation 75.6	0.113 µmol/L Geometric Coefficient of Variation 64.5	—
Maximum Plasma Concentration (Cmax) of MK-8527 Week 20	0.0320 µmol/L Geometric Coefficient of Variation 67.5	0.0538 µmol/L Geometric Coefficient of Variation 73.5	0.108 µmol/L Geometric Coefficient of Variation 72.5	—

Adverse Events

MK-8527 3 mg QM

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

MK-8527 6 mg QM

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

MK-8527 12 mg QM

Serious events: 1 serious events

Other events: 32 other events

Deaths: 1 deaths

Placebo to MK-8527

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MK-8527 3 mg QM n=101 participants at risk Participants received oral MK-8527 3 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 6 mg QM n=101 participants at risk Participants received oral MK-8527 6 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 12 mg QM n=99 participants at risk Participants received oral MK-8527 12 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	Placebo to MK-8527 n=49 participants at risk Participants received oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
Gastrointestinal disorders Abdominal pain	0.99% 1/101 • Number of events 1 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.00% 0/101 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.00% 0/99 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.00% 0/49 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/101 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.00% 0/101 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	1.0% 1/99 • Number of events 1 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.00% 0/49 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/101 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.00% 0/101 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.00% 0/99 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	2.0% 1/49 • Number of events 1 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.99% 1/101 • Number of events 1 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.00% 0/101 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.00% 0/99 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.00% 0/49 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.

Other adverse events

Other adverse events
Measure	MK-8527 3 mg QM n=101 participants at risk Participants received oral MK-8527 3 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 6 mg QM n=101 participants at risk Participants received oral MK-8527 6 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	MK-8527 12 mg QM n=99 participants at risk Participants received oral MK-8527 12 mg QM for 6 months, followed by an 8-week blinded safety follow-up period.	Placebo to MK-8527 n=49 participants at risk Participants received oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
Gastrointestinal disorders Nausea	4.0% 4/101 • Number of events 4 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	7.9% 8/101 • Number of events 9 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	3.0% 3/99 • Number of events 3 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	2.0% 1/49 • Number of events 2 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.
General disorders Fatigue	5.0% 5/101 • Number of events 7 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	7.9% 8/101 • Number of events 11 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	7.1% 7/99 • Number of events 7 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	6.1% 3/49 • Number of events 3 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.
Infections and infestations COVID-19	2.0% 2/101 • Number of events 2 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	4.0% 4/101 • Number of events 4 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	5.1% 5/99 • Number of events 5 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	4.1% 2/49 • Number of events 2 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.
Infections and infestations Nasopharyngitis	3.0% 3/101 • Number of events 3 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	2.0% 2/101 • Number of events 2 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	2.0% 2/99 • Number of events 2 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	8.2% 4/49 • Number of events 4 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.
Infections and infestations Upper respiratory tract infection	15.8% 16/101 • Number of events 19 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	9.9% 10/101 • Number of events 11 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	10.1% 10/99 • Number of events 11 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	12.2% 6/49 • Number of events 8 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.
Investigations Blood creatine phosphokinase increased	3.0% 3/101 • Number of events 5 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.99% 1/101 • Number of events 1 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	3.0% 3/99 • Number of events 3 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	6.1% 3/49 • Number of events 3 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.
Investigations CD4 lymphocytes decreased	4.0% 4/101 • Number of events 4 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	3.0% 3/101 • Number of events 3 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	5.1% 5/99 • Number of events 6 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	2.0% 1/49 • Number of events 2 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.
Investigations Lymphocyte count decreased	0.00% 0/101 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.99% 1/101 • Number of events 1 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	6.1% 6/99 • Number of events 6 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	2.0% 1/49 • Number of events 2 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.
Nervous system disorders Headache	8.9% 9/101 • Number of events 9 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	6.9% 7/101 • Number of events 7 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	1.0% 1/99 • Number of events 1 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.00% 0/49 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 5/101 • Number of events 5 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	6.9% 7/101 • Number of events 7 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	1.0% 1/99 • Number of events 1 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	0.00% 0/49 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.0% 4/101 • Number of events 5 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	4.0% 4/101 • Number of events 5 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	5.1% 5/99 • Number of events 5 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.	4.1% 2/49 • Number of events 2 • Up to ~28 weeks All randomized participants who received ≥1 dose of study therapy are included.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
Publication restrictions are in place

Restriction type: OTHER