HIVPhase 2NCT06045507
Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
A Phase 2 study testing MK-8527 in people with HIV and HIV Pre-exposure Prophylaxis, run by Merck Sharp & Dohme LLC at 18 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, HIV Pre-exposure Prophylaxis
- What is being tested?
- MK-8527
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 8 Nov 2023to 12 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
- Has low-risk of HIV infection
- Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses an acceptable contraception or is abstinent from penile-vaginal intercourse
Who cannot join
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid [RNA])
- Prior use of MK-8527 or islatravir (MK-8591)
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States10 sites
Albuquerque Clinical Trials, Inc. ( Site 0044)
Albuquerque, New Mexico, 87102
Fenway Health ( Site 0043)
Boston, Massachusetts, 02215
Prism Health North Texas, Oak Cliff Health Center ( Site 0045)
Dallas, Texas, 75208
Velocity Clinical Research, Hallandale Beach ( Site 0052)
Hallandale, Florida, 33009
Community Medical Care Center ( Site 0056)
Immokalee, Florida, 34142
Velocity Clinical Research, North Hollywood ( Site 0054)
North Hollywood, California, 91606
University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0041)
Pittsburgh, Pennsylvania, 15213
Velocity Clinical Research Rockville ( Site 0048)
Rockville, Maryland, 20854
Bridge HIV- San Francisco Department of Public Health ( Site 0042)
San Francisco, California, 94102
Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0057)
Seattle, Washington, 98104
South Africa5 sites
Josha Research ( Site 0023)
Bloemfontein, Free State, 9301
Desmond Tutu Health Foundation ( Site 0021)
Cape Town, Western Cape, 7925
Wits RHI-Wits RHI Ward 21 Clinical Research site ( Site 0027)
Johannesburg, Gauteng, 2000
Helen Joseph Hospital ( Site 0024)
Johannesburg, Gauteng, 2092
Qhakaza Mbokodo Research Clinic ( Site 0026)
Ladysmith, KwaZulu-Natal, 3370
Israel3 sites
Rambam Health Care Campus ( Site 0003)
Haifa, 3109601
Hadassah Medical Center ( Site 0002)
Jerusalem, 9112001
Sheba Medical Center ( Site 0001)
Ramat Gan, 5265601
About this study
Official title: A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8527 Once Monthly in Participants at Low-Risk for HIV-1 Infection
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.
- Conditions
- HIV, HIV Pre-exposure Prophylaxis
- Being tested
- MK-8527, Placebo to MK-8527
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8527Drug
MK-8527 capsule
Placebo to MK-8527Drug
Placebo capsule matched to MK-8527
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: MK-8527 |
| 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. Receives: Drug: MK-8527 |
| 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. Receives: Drug: MK-8527 |
| 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. Receives: Drug: Placebo to MK-8527 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to ~20 weeks
Secondary outcomes (2)
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.
Measured: 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
The plasma Cmax of MK-8527 is reported.
Measured: Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 Nov 2023
- Primary completion12 Dec 2024
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045507
- Sponsor's protocol ID
- 8527-007
- Status last verified
- Jan 2026
- First submitted
- 13 Sep 2023
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Mayer KH, Kotze P, Lombaard J, Caraco Y, Peer A, Poovan N, Khalsa S, Khetan S, Shapiro AE, Rassool M, Gonzalez A, Singh Y, Sinclair G, Riddler SA, Buchbinder S, Ben-Ami E, Turner M, Vesay M, Homony B, Evans B, Grandhi A, Zhang C, Robertson MN, Kapoor Y, Matthews RP, Plank RM. Alimatravir Oral Once Monthly in Adults With Low Likelihood of HIV Exposure: A Randomized, Double-Blind, Placebo-Controlled Study. J Infect Dis. 2026 Sep 22:jiag439. doi: 10.1093/infdis/jiag439. Online ahead of print.
PubMed 42770214
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8527 Once Monthly in Participants at Low-Risk for HIV-1 Infection
- ClinicalTrials.gov ID
- NCT06045507
- Acronym / sponsor ID
- 8527-007
- Conditions
- HIV, HIV Pre-exposure Prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Posted 7 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MK-8527 Low Dose QM | Experimental | Drug: MK-8527Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period. |
| MK-8527 Medium Dose QM | Experimental | Drug: MK-8527Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period. |
| MK-8527 High Dose QM | Experimental | Drug: MK-8527Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period. |
| Placebo to MK-8527 | Placebo comparator | Drug: Placebo to MK-8527Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
- Has low-risk of HIV infection
- Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses an acceptable contraception or is abstinent from penile-vaginal intercourse
Key exclusion criteria (3 listed)
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid [RNA])
- Prior use of MK-8527 or islatravir (MK-8591)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-8527MK-8527 capsule | Drug | MK-8527 High Dose QM, MK-8527 Low Dose QM, MK-8527 Medium Dose QM |
| Placebo to MK-8527Placebo capsule matched to MK-8527 | Drug | Placebo to MK-8527 |
Primary outcome
Number of Participants With ≥1 Adverse Event (AE)
Time frame: Up to ~28 weeks
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.
Number of Participants Discontinuing Study Therapy Due to Adverse Event (AE)
Time frame: Up to ~20 weeks
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.
2 secondary outcomes
Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527
Time frame: 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
Time frame: Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42770214Mayer KH, Kotze P, Lombaard J, Caraco Y, Peer A, Poovan N, Khalsa S, Khetan S, Shapiro AE, Rassool M, Gonzalez A, Singh Y, Sinclair G, Riddler SA, Buchbinder S, Ben-Ami E, Turner M, Vesay M, Homony B, Evans B, Grandhi A, Zhang C, Robertson MN, Kapoor Y, Matthews RP, Plank RM. Alimatravir Oral Once Monthly in Adults With Low Likelihood of HIV Exposure: A Randomized, Double-Blind, Placebo-Controlled Study. J Infect Dis. 2026 Sep 22:jiag439. doi: 10.1093/infdis/jiag439. Online ahead of print.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-8527 in people with HIV and HIV Pre-exposure Prophylaxis, run by Merck Sharp & Dohme LLC at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, South Africa, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With ≥1 Adverse Event (AE) (time frame: Up to ~28 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06045507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.