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This double-blind, placebo-controlled study was designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-8527 Low Dose QM | Experimental | Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period. |
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| MK-8527 Medium Dose QM | Experimental | Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period. |
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| MK-8527 High Dose QM | Experimental | Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period. |
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| Placebo to MK-8527 | Placebo Comparator | Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8527 | Drug | MK-8527 capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With ≥1 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. | Up to ~28 weeks |
| Number of Participants Discontinuing Study Therapy Due to 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. | Up to ~20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527 | The plasma AUC0-last of MK-8527 is reported. | Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose |
| Maximum Plasma Concentration (Cmax) of MK-8527 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research, North Hollywood ( Site 0054) | North Hollywood | California | 91606 | United States | ||
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Adult participants who were at low risk of human immunodeficiency virus Type 1 (HIV-1) infection were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 3, 2024 | Dec 2, 2025 |
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| Placebo to MK-8527 | Drug | Placebo capsule matched to MK-8527 |
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The plasma Cmax of MK-8527 is reported. |
| Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose |
| Bridge HIV- San Francisco Department of Public Health ( Site 0042) |
| San Francisco |
| California |
| 94102 |
| United States |
| Velocity Clinical Research, Hallandale Beach ( Site 0052) | Hallandale | Florida | 33009 | United States |
| Community Medical Care Center ( Site 0056) | Immokalee | Florida | 34142 | United States |
| Velocity Clinical Research Rockville ( Site 0048) | Rockville | Maryland | 20854 | United States |
| Fenway Health ( Site 0043) | Boston | Massachusetts | 02215 | United States |
| Albuquerque Clinical Trials, Inc. ( Site 0044) | Albuquerque | New Mexico | 87102 | United States |
| University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0041) | Pittsburgh | Pennsylvania | 15213 | United States |
| Prism Health North Texas, Oak Cliff Health Center ( Site 0045) | Dallas | Texas | 75208 | United States |
| Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0057) | Seattle | Washington | 98104 | United States |
| Rambam Health Care Campus ( Site 0003) | Haifa | 3109601 | Israel |
| Hadassah Medical Center ( Site 0002) | Jerusalem | 9112001 | Israel |
| Sheba Medical Center ( Site 0001) | Ramat Gan | 5265601 | Israel |
| Josha Research ( Site 0023) | Bloemfontein | Free State | 9301 | South Africa |
| Wits RHI-Wits RHI Ward 21 Clinical Research site ( Site 0027) | Johannesburg | Gauteng | 2000 | South Africa |
| Helen Joseph Hospital ( Site 0024) | Johannesburg | Gauteng | 2092 | South Africa |
| Qhakaza Mbokodo Research Clinic ( Site 0026) | Ladysmith | KwaZulu-Natal | 3370 | South Africa |
| Desmond Tutu Health Foundation ( Site 0021) | Cape Town | Western Cape | 7925 | South Africa |
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-8527 3 mg QM | Participants received oral MK-8527 3 mg QM for 6 months, followed by an 8-week blinded safety follow-up period. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||
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| Primary | Number of Participants With ≥1 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. | All randomized participants who received ≥1 dose of study therapy are included. | Posted | Count of Participants | Participants | Up to ~28 weeks |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527 | The plasma AUC0-last of MK-8527 is reported. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*µmol/L | Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose |
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| Primary | Number of Participants Discontinuing Study Therapy Due to 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. | All randomized participants who received ≥1 dose of study therapy are included. | Posted | Count of Participants | Participants | Up to ~20 weeks |
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| Secondary | Maximum Plasma Concentration (Cmax) of MK-8527 | The plasma Cmax of MK-8527 is reported. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | µmol/L | Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose |
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Up to ~28 weeks
All randomized participants who received ≥1 dose of study therapy are included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-8527 3 mg QM | Participants received oral MK-8527 3 mg QM for 6 months, followed by an 8-week blinded safety follow-up period. | 0 | 101 | 2 | 101 | 38 | 101 |
| EG001 | 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. | 0 | 101 | 0 | 101 | 43 | 101 |
| EG002 | 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. | 1 | 99 | 1 | 99 | 32 | 99 |
| EG003 | 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. | 0 | 49 | 1 | 49 | 21 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 27.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| CD4 lymphocytes decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2024 | Dec 2, 2025 | SAP_001.pdf |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants received oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period. |
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