Human Immunodeficiency VirusPhase 1NCT05494736
MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)
A Phase 1 study testing MK-8527 in people with Human Immunodeficiency Virus, run by Merck Sharp & Dohme LLC at 4 sites in 2 countries.
Trial summary
This is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8527 in antiretroviral therapy (ART)-naïve participants living with human immunodeficiency virus type 1 (HIV-1) infection. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- MK-8527
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 17 Nov 2022to 31 Jan 2024
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Is in good health other than HIV-1 infection
- Is documented HIV-1 positive
- Is ART-naïve, which is defined as not having received any marketed antiretroviral agent for treatment of HIV-1 infection (prior use of an ART for PrEP or investigational therapy is permitted if the last dose was ≥30 days prior to study drug administration)
- Is willing to receive no other ART for the monitoring period of this study
Who cannot join
- Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study, until the poststudy visit
- Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
South Africa3 sites
Josha Research ( Site 0003)
Bloemfontein, Free State, 9301
Desmond Tutu Health Foundation ( Site 0001)
Cape Town, Western Cape, 7925
Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0002)
Johannesburg, Gauteng, 2092
Romania1 site
ARENSIA Exploratory Medicine-Institutul National de Boli Infectioase Matei Bals ( Site 0004)
Bucharest, Bucharest
About this study
Official title: A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants
This is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8527 in antiretroviral therapy (ART)-naïve participants living with human immunodeficiency virus type 1 (HIV-1) infection. The primary hypothesis is that, at a dose that is safe and generally well tolerated, MK-8527 will have antiretroviral activity as measured by a reduction from baseline in plasma HIV-1 ribonucleic acid (RNA) of ≥1.0 log10 copies/mL. A total of 4 arms was initially planned but Arm D was never initiated as the primary objectives were achieved following completion of Arms A to C.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- MK-8527
- 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
MK-8527 capsule taken by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Panel A: MK-8527 1.0 mg | Experimental | Participants receive a single oral dose of MK-8527 1.0 mg. Receives: Drug: MK-8527 |
| Panel B: MK-8527 0.5 mg | Experimental | Participants receive a single oral dose of MK-8527 0.5 mg. Receives: Drug: MK-8527 |
| Panel C: MK-8527 0.25 mg | Experimental | Participants receive a single oral dose of MK-8527 0.25 mg. Receives: Drug: MK-8527 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)
The mean change from baseline in HIV-1 RNA counts at 168 hours after a single doses of MK-8527 is reported.
Measured: Baseline and 168 hours postdose on Day 1
Number of Participants Experiencing ≥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 days
Number of Participants Discontinuing From Study Due to an 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 days
Secondary outcomes (14)
Area Under the Concentration-Time Curve From Predose to 168 Hours Postdose (AUC0-168) of MK-8527 Triphosphate (MK-8527-TP) in Peripheral Blood Mononuclear Cells (PBMCs)
The AUC0-168 of MK-8527-TP in PBMCs is reported.
Measured: Predose and 4, 12, 24, 96, 120, 144, and 168 hours postdose
Area Under the Concentration-Time Curve From Predose to Infinity (AUC0-inf) of MK-8527-TP in PBMCs
The MK-8527-TP AUC0-inf in PBMCs is reported.
Measured: Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose
Area Under the Concentration-Time Curve From Predose to Last Measurable Concentration (AUC0-last) of MK-8527-TP in PBMCs
The MK-8527-TP AUC0-last in PBMCs is reported.
Measured: Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose
Maximum Concentration (Cmax) of MK-8527-TP in PBMCs
The MK-8527-TP Cmax in PBMCs is reported.
Measured: Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose
Concentration at 168 Hours Postdose (C168) of MK-8527-TP in PBMCs
The C168 of MK-8527-TP in PBMCs is reported.
Measured: 168 hours postdose
Time to Maximum Concentration (Tmax) of MK-8527-TP in PBMCs
The MK-8527-TP Tmax in PBMCs is reported.
Measured: Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose
Apparent Terminal Half-life (t½) of MK-8527-TP in PBMCs
The apparent t½ of MK-8527-TP in PBMCs is reported.
Measured: Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose
AUC0-inf of MK-8527 in Plasma
The AUC0-inf of MK-8527 in plasma is reported.
Measured: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose
AUC0-last of MK-8527 in Plasma
The AUC0-last of MK-8527 in plasma is reported.
Measured: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose
Clast of MK-8527 in Plasma
The Clast of MK-8527 in plasma is reported.
Measured: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose
Cmax of MK-8527 in Plasma
The Cmax of MK-8527 in plasma is reported.
Measured: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose
Tmax of MK-8527 in Plasma
The Tmax of MK-8527 in plasma is reported.
Measured: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose
Apparent t½ of MK-8527 in Plasma
The apparent t½ of MK-8527 in plasma is reported.
Measured: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose
Correlation Between Intracellular C168 of MK-8527-TP in PBMCs and Change From Baseline in Plasma HIV-1 RNA
The correlation between between the C168 of MK-8527-TP in PBMCs and the change from baseline in plasma HIV-1 RNA levels 168 hours after dosing was calculated based on all pooled participants. All participants who complied with the protocol sufficiently to ensure that generated data will belikely to exhibit the effects of treatment, according to the underlying scientific model, are included. Participants with data below the LLOQ are excluded.
Measured: Predose and 168 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start17 Nov 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
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 Human Immunodeficiency VirusStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT05494736
- Sponsor's protocol ID
- 8527-004
- Other IDs
- MK-8527-004, 2023-503682-39, U1111-1287-7295, 2023
- Status last verified
- Mar 2025
- First submitted
- 2 Aug 2022
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Carstens RP, Kapoor Y, Vargo RC, Bhattacharyya A, Garrett G, Cilissen C, Adedoyin A, Zang X, Denef JF, Leyssens C, Reynders T, Preotescu L, Kaplan R, Rassool M, Lombaard J, Streinu-Cercel A, Matthews RP, Stoch SA, Iwamoto M, Gillespie GL. Antiretroviral Activity, Pharmacokinetics, and Safety of MK-8527, an Oral Nucleoside Reverse Transcriptase Translocation Inhibitor, in Adults With HIV-1 Who Had Not Previously Taken Antiretroviral Agents: Results From 2 Open-Label, Phase 1 Studies. Clin Infect Dis. 2026 May 20;82(5):e984-e991. doi: 10.1093/cid/ciag135.
PubMed 41830320
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants
- ClinicalTrials.gov ID
- NCT05494736
- Acronym / sponsor ID
- 8527-004
- Conditions
- Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8527 in antiretroviral therapy (ART)-naïve participants living with human immunodeficiency virus type 1 (HIV-1) infection. The primary hypothesis is that, at a dose that is safe and generally well tolerated, MK-8527 will have antiretroviral activity as measured by a reduction from baseline in plasma HIV-1 ribonucleic acid (RNA) of ≥1.0 log10 copies/mL. A total of 4 arms was initially planned but Arm D was never initiated as the primary objectives were achieved following completion of Arms A to C.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Panel A: MK-8527 1.0 mg | Experimental | Drug: MK-8527Participants receive a single oral dose of MK-8527 1.0 mg. |
| Panel B: MK-8527 0.5 mg | Experimental | Drug: MK-8527Participants receive a single oral dose of MK-8527 0.5 mg. |
| Panel C: MK-8527 0.25 mg | Experimental | Drug: MK-8527Participants receive a single oral dose of MK-8527 0.25 mg. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Is in good health other than HIV-1 infection
- Is documented HIV-1 positive
- Is ART-naïve, which is defined as not having received any marketed antiretroviral agent for treatment of HIV-1 infection (prior use of an ART for PrEP or investigational therapy is permitted if the last dose was ≥30 days prior to study drug administration)
- Is willing to receive no other ART for the monitoring period of this study
Key exclusion criteria (3 listed)
- Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study, until the poststudy visit
- Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit
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 taken by mouth. | Drug | Panel A: MK-8527 1.0 mg, Panel B: MK-8527 0.5 mg, Panel C: MK-8527 0.25 mg |
Primary outcome
Change From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)
Time frame: Baseline and 168 hours postdose on Day 1
The mean change from baseline in HIV-1 RNA counts at 168 hours after a single doses of MK-8527 is reported.
Number of Participants Experiencing ≥1 Adverse Event (AE)
Time frame: Up to 28 days
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 From Study Due to an AE
Time frame: Up to 28 days
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.
14 secondary outcomes
Area Under the Concentration-Time Curve From Predose to 168 Hours Postdose (AUC0-168) of MK-8527 Triphosphate (MK-8527-TP) in Peripheral Blood Mononuclear Cells (PBMCs)
Time frame: Predose and 4, 12, 24, 96, 120, 144, and 168 hours postdose
Area Under the Concentration-Time Curve From Predose to Infinity (AUC0-inf) of MK-8527-TP in PBMCs
Time frame: Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose
Area Under the Concentration-Time Curve From Predose to Last Measurable Concentration (AUC0-last) of MK-8527-TP in PBMCs
Time frame: Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose
Maximum Concentration (Cmax) of MK-8527-TP in PBMCs
Time frame: Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose
Concentration at 168 Hours Postdose (C168) of MK-8527-TP in PBMCs
Time frame: 168 hours postdose
Time to Maximum Concentration (Tmax) of MK-8527-TP in PBMCs
Time frame: Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose
Apparent Terminal Half-life (t½) of MK-8527-TP in PBMCs
Time frame: Predose and 4, 12, 24, 96, 120, 144, 168, 192, 240, 336, 504, and 672 hours postdose
AUC0-inf of MK-8527 in Plasma
Time frame: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose
AUC0-last of MK-8527 in Plasma
Time frame: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose
Clast of MK-8527 in Plasma
Time frame: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose
Cmax of MK-8527 in Plasma
Time frame: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose
Tmax of MK-8527 in Plasma
Time frame: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose
Apparent t½ of MK-8527 in Plasma
Time frame: Predose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose
Correlation Between Intracellular C168 of MK-8527-TP in PBMCs and Change From Baseline in Plasma HIV-1 RNA
Time frame: Predose and 168 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41830320Carstens RP, Kapoor Y, Vargo RC, Bhattacharyya A, Garrett G, Cilissen C, Adedoyin A, Zang X, Denef JF, Leyssens C, Reynders T, Preotescu L, Kaplan R, Rassool M, Lombaard J, Streinu-Cercel A, Matthews RP, Stoch SA, Iwamoto M, Gillespie GL. Antiretroviral Activity, Pharmacokinetics, and Safety of MK-8527, an Oral Nucleoside Reverse Transcriptase Translocation Inhibitor, in Adults With HIV-1 Who Had Not Previously Taken Antiretroviral Agents: Results From 2 Open-Label, Phase 1 Studies. Clin Infect Dis. 2026 May 20;82(5):e984-e991. doi: 10.1093/cid/ciag135.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-8527 in people with Human Immunodeficiency Virus, run by Merck Sharp & Dohme LLC at 4 sites in 2 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 4 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 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa, Romania. 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. 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?
Yes. Results are posted in the registry (first posted 26 Mar 2025). 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?
Change From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA) (time frame: Baseline and 168 hours postdose on Day 1). The study lists 3 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 NCT05494736, 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 26 Mar 2025.