Human Immunodeficiency Virus (HIV)Phase 1NCT07600775
A Clinical Trial of MK-8527 and Rifampin in Adult Participants With Latent Tuberculosis Infection (MK-8527-019)
A Phase 1 study testing MK-8527 and Rifampin in people with Human Immunodeficiency Virus (HIV) and HIV Pre-Exposure Prophylaxis, run by Merck Sharp & Dohme LLC.
Trial summary
Researchers are studying MK-8527, a new medicine for preventing HIV-1 (human immunodeficiency virus type 1) infection and want to learn if MK-8527 can be given together with rifampin. Rifampin is commonly used to treat people with latent tuberculosis infection (LTBI). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
- What is being tested?
- MK-8527 and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 19 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has a diagnosis of untreated latent tuberculosis infection (LTBI)
- Has no symptoms of active tuberculosis (TB)
- Has never received treatment for TB or LTBI
- Other than having LTBI, is in good health
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has a diagnosis of LTBI made in the context of an outbreak/contact-tracing investigation
- Has a current or anticipated immunocompromised state
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
- Has a history of cancer (malignancy)
- Has a history of active TB
- Has positive test results for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus
About this study
Official title: An Open-label, Phase 1 Study to Characterize the Effects of Rifampin on the Pharmacokinetics of MK-8527 in Adult Participants With Latent Tuberculosis Infection
Researchers are studying MK-8527, a new medicine for preventing HIV-1 (human immunodeficiency virus type 1) infection and want to learn if MK-8527 can be given together with rifampin. Rifampin is commonly used to treat people with latent tuberculosis infection (LTBI).
The main goal of this study is to learn what happens to MK-8527 in the body over time when given with and without the medication rifampin in participants with LTBI.
- Being tested
- MK-8527, Rifampin
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8527Drug
Administered orally
RifampinDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| MK-8527 + Rifampin | Experimental | Participants receive single doses of MK-8527 alone and in combination with daily doses of rifampin. Receives: Drug: MK-8527; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MK-8527
Blood samples will be collected to determine the AUC0-inf of MK-8527 in plasma.
Measured: At designated time points (up to approximately 2 weeks)
Secondary outcomes (9)
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of MK-8527
Blood samples will be collected to determine AUC0-last of MK-8527 in plasma.
Measured: At designated time points (up to approximately 2 weeks)
Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC0-336) of MK-8527
Blood samples will be collected to determine AUC0-336 of MK-8527 in plasma.
Measured: At designated time points (up to approximately 2 weeks)
Maximum Plasma Concentration (Cmax) of MK-8527
Blood samples will be collected to determine Cmax of MK-8527 in plasma.
Measured: At designated time points (up to approximately 2 weeks)
Time to Maximum Plasma Concentration (Tmax) of MK-8527
Blood samples will be collected to determine Tmax of MK-8527 in plasma.
Measured: At designated time points (up to approximately 2 weeks)
Terminal Elimination Half-Life (T1/2) of MK-8527
Blood samples will be collected to determine t1/2 of MK-8527 in plasma.
Measured: At designated time points (up to approximately 2 weeks)
Apparent Clearance (CL/F) of MK-8527
Blood samples will be collected to determine CL/F of MK-8527 in plasma.
Measured: At designated time points (up to approximately 2 weeks)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527
Blood samples will be collected to determine Vz/F of MK-8527 in plasma.
Measured: At designated time points (up to approximately 2 weeks)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to approximately 8 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion19 Jan 2027 (estimated)
- Study completion19 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
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
- NCT07600775
- Sponsor's protocol ID
- 8527-019
- Other IDs
- MK-8527-019
- Status last verified
- Jul 2026
- First submitted
- 15 May 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1 Study to Characterize the Effects of Rifampin on the Pharmacokinetics of MK-8527 in Adult Participants With Latent Tuberculosis Infection
- ClinicalTrials.gov ID
- NCT07600775
- Acronym / sponsor ID
- 8527-019
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 19 Jan 2027 (estimated)
- Study completion
- 19 Jan 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are studying MK-8527, a new medicine for preventing HIV-1 (human immunodeficiency virus type 1) infection and want to learn if MK-8527 can be given together with rifampin. Rifampin is commonly used to treat people with latent tuberculosis infection (LTBI).
The main goal of this study is to learn what happens to MK-8527 in the body over time when given with and without the medication rifampin in participants with LTBI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK-8527 + Rifampin | Experimental | Drug: MK-8527, Drug: RifampinParticipants receive single doses of MK-8527 alone and in combination with daily doses of rifampin. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Has a diagnosis of untreated latent tuberculosis infection (LTBI)
- Has no symptoms of active tuberculosis (TB)
- Has never received treatment for TB or LTBI
- Other than having LTBI, is in good health
Key exclusion criteria (7 listed)
- Has a diagnosis of LTBI made in the context of an outbreak/contact-tracing investigation
- Has a current or anticipated immunocompromised state
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
- Has a history of cancer (malignancy)
- Has a history of active TB
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-8527Administered orally | Drug | MK-8527 + Rifampin |
| RifampinAdministered orally | Drug | MK-8527 + Rifampin |
Primary outcome
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MK-8527
Time frame: At designated time points (up to approximately 2 weeks)
Blood samples will be collected to determine the AUC0-inf of MK-8527 in plasma.
9 secondary outcomes
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of MK-8527
Time frame: At designated time points (up to approximately 2 weeks)
Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC0-336) of MK-8527
Time frame: At designated time points (up to approximately 2 weeks)
Maximum Plasma Concentration (Cmax) of MK-8527
Time frame: At designated time points (up to approximately 2 weeks)
Time to Maximum Plasma Concentration (Tmax) of MK-8527
Time frame: At designated time points (up to approximately 2 weeks)
Terminal Elimination Half-Life (T1/2) of MK-8527
Time frame: At designated time points (up to approximately 2 weeks)
Apparent Clearance (CL/F) of MK-8527
Time frame: At designated time points (up to approximately 2 weeks)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527
Time frame: At designated time points (up to approximately 2 weeks)
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 8 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- 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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-8527 and Rifampin in people with Human Immunodeficiency Virus (HIV) and HIV Pre-Exposure Prophylaxis, run by Merck Sharp & Dohme LLC.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MK-8527 (time frame: At designated time points (up to approximately 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.