Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
4,750
Countries
1
Sites
3
HIV-1 prevention
1. To evaluate the efficacy of MK-8527 qm compared to FTC/TDF qd for the prevention of HIV-1 infection as assessed by the incidence rate per year of adjudicated HIV-1 infections. 2. To evaluate the safety and tolerability of MK-8527 qm compared to FTC/TDF qd.
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 19 Nov 2025 → ongoing
- Decision date (initial)
- 2025-10-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2025-520610-58-00
- WHO UTN
- U1111-1317-6239
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenetic, Prophylaxis, Efficacy, Pharmacokinetic, Pharmacogenomic, Pharmacodynamic, Safety
1. To evaluate the efficacy of MK-8527 qm compared to FTC/TDF qd for the prevention of HIV-1 infection as assessed by the incidence rate per year of adjudicated HIV-1 infections.
2. To evaluate the safety and tolerability of MK-8527 qm compared to FTC/TDF qd.
Conditions and MedDRA coding
HIV-1 prevention
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10020192 | HIV-1 | 10021881 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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
- Is ≥16 years of age
- Weighs ≥35 kg
Exclusion criteria 7
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1(HIV-1) Infection
- Number of Participants Who Experience At Least One Adverse Event (AE)
- Number of Participants Who Discontinue Study Intervention Due to an AE
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD12465760 · Product
- Active substance
- MK-8527
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 11 mg milligram(s)
- Max total dose
- 330 mg milligram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
SCP104867981 · ATC
- Active substance
- Emtricitabine
- Route of administration
- ORAL USE
- Max daily dose
- 445 mg milligram(s)
- Max total dose
- 386260 mg milligram(s)
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- J05AR03 — TENOFOVIR DISOPROXIL AND EMTRICITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 2
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Placebo for Emtricitabine/Tenofovir Disoproxil
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Christopher Bruno
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Christopher Bruno
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Pharma Medica Research Inc. ORG-100011951
|
Mississauga, Canada | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| University Of Colorado Foundation ORG-100046648
|
Aurora, United States | Laboratory analysis |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Monogram Biosciences Inc. ORG-100043273
|
South San Francisco, United States | Laboratory analysis |
| AG Mednet Inc. ORG-100039869
|
Boston, United States | Other |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Interactive response technologies (IRT) |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 100 | 3 |
| Rest of world
South Africa, Colombia, Peru, Switzerland, United States, Vietnam, Thailand, Malaysia, Guatemala, Philippines, Kenya, Argentina, Chile, Brazil
|
— | 4,650 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Service des Maladies Infectieuses et Tropicales, 1 Avenue Claude Vellefaux, 75010, Paris
Assistance Publique Hopitaux De Paris
Service des Maladies Infectieuses et Tropicales, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Assistance Publique Hopitaux De Paris
Service des Maladies Infectieuses, 4 Rue De La Chine, 75020, Paris
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-11-19 | 2025-11-24 | 2026-05-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-520610-58_IN-RFI004_for pub | 01R |
| Protocol (for publication) | D4_Copyright statement_EN_EQ-5D-5L_IN_for pub | 04DEC2024 |
| Protocol (for publication) | D4_Copyright statement_EN_Study Medication Preference_IN_for pub | 04DEC2024 |
| Protocol (for publication) | D4_Copyright statement_EN_Study medication satisfaction_IN_for pub | 04DEC2024 |
| Protocol (for publication) | D4_Copyright statement_IN_Sexual Substance Use and Social_for pub | 04DEC2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_SM02_for pub | 05JAN2026 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_FRA_FR_SM02_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Flyer_FRA_FR_SM02_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_FRA_FR_SM02_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Social Media_FRA_FR_SM02_for pub | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_1 month of FTC-TDF_FRA_FR_NSM01_for pub | v0-01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Medication during breastfeeding_FRA_FR_NSM01_for pub | v0-01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_Medication during pregnancy_FRA_FR_NSM01_for pub | v0-01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_NSM01_for pub | v0-01R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_infant follow-up_FRA_FR_NSM01_for pub | v0-01R |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_EMTRICITABINE-TENOFOVIR Gilead Science_IN_for pub | 07MAR2024 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-520610-58_FRA_FR_IN_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2025-520610-58_IN_for pub | 1.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-16 | France | Acceptable with conditions 2025-09-12
|
2025-10-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-06 | France | Acceptable with conditions 2025-11-05
|
2025-11-10 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-12 | France | Acceptable with conditions 2025-11-05
|
2025-11-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-07 | France | Acceptable with conditions | 2026-02-03 |