MK6186 in HIV-1 Infected Patients (MK-6186-007 AM2)

A Phase 1 study testing MK6186 in people with HIV-1 Infection, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study will evaluate the safety and tolerability of MK6186 and the change from baseline in plasma HIV-1 RNA after seven consecutive days of dosing. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: HIV-1 Infection
What is being tested?: MK6186
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: No sites listed yet
Study dates: 10 Oct 2010to 30 Jun 2011
Phase: Phase 1
Are there results?: None posted in the registry

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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Other than HIV infection, patient's baseline health is judged to be stable
Patient is documented HIV-1 positive
Patient has not received an investigational agent or licensed ART with in the past 30 days

Who cannot join

Patient has a history of stroke, chronic seizures, or major neurological disease
Patient has a history of cancer
Patient has used any immune therapy agents or immunosuppressive therapy within the past month
Patient requires or anticipates the use of any prescription or non-prescription drugs during the study
Patient has a current diagnosis of acute hepatitis, has a history of Hepatitis C or has positive Hepatitis B surface antigen
Patient consumes excessive amounts of alcohol (greater than 3 servings per day) or caffeine (greater than 6 servings per day)
Patient is an excessive smoker (more than 10 cigarettes per day)
Patient has had major surgery, donated blood or participated in another investigational study within the past 4 weeks

About this study

Official title: A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK6186 in HIV-1 Infected Patients

This study will evaluate the safety and tolerability of MK6186 and the change from baseline in plasma HIV-1 RNA after seven consecutive days of dosing.

Conditions: HIV-1 Infection
Being tested: MK6186, Comparator: Placebo
Keywords: Treatment of HIV-1 Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK6186Drug
Panel A: 40 mg oral dose once daily for 7 days Panel B: 150 mg oral dose once daily for 7 days Panel C: Oral Dose <= 150 mg once daily for 7 days (dose level will be determined based on pharmacokinetic and pharmacodynamic results of panel A and B) Panel D: Oral Dose <= 150 mg once twice or three times daily for 7 days (dose level and dose frequency will be determined based on pharmacokinetic and pharmacodynamic results of panel A, B and C)
Comparator: PlaceboDrug
Placebo tablets taken orally for seven day

Study groups in NCT01152255
Study group	Role	What they receive
Panel A - MK6186 40 mg	Experimental	MK6186 40 mg Receives: Drug: MK6186
Panel A - Placebo	Placebo comparator	placebo Receives: Drug: Comparator: Placebo
Panel B - MK6186 150 mg	Experimental	MK6186 150 mg Receives: Drug: MK6186
Panel B - Placebo	Placebo comparator	placebo Receives: Drug: Comparator: Placebo
Panel C - MK6186 <=150 mg	Experimental	MK6186 <=150 mg Receives: Drug: MK6186
Panel C - Placebo	Placebo comparator	placebo Receives: Drug: Comparator: Placebo
Panel D - MK6186 <=150 mg	Experimental	MK6186 <=150 mg Receives: Drug: MK6186
Panel D - Placebo	Placebo comparator	placebo Receives: Drug: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in plasma HIV-1 RNA
Measured: Baseline and Day 7
Safety and tolerability of MK6186 measured by number of clinical and laboratory adverse experiences
Measured: through Day 21

Secondary outcomes (1)

C(24 hour) of MK6186
Measured: Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 201030 Jun 2011

First posted29 Jun 2010 (estimated)
Study start10 Oct 2010
Primary completion30 Jun 2011
Study completion30 Jun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV-1 InfectionStudies 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01152255
Sponsor's protocol ID: 6186-007
Other IDs: 2010_542, 2010-020829-41
Status last verified: Jul 2025
First submitted: 25 Jun 2010
Last updated: 23 Jul 2025
Results posted: No
Data monitoring committee: No

Publications

Schurmann D, Huser A, Pfafflin F, Cilissen C, De Lepeleire I, Larson PJ, Anderson MS, Rizk ML, Hofmann J, Daumer M, Stegemann MS, Stoch SA, Wagner F, Iwamoto M. A Randomized, Double-Blind, Placebo-Controlled, Short-Term Monotherapy Study of MK-6186, an HIV-1 Non-Nucleoside Reverse Transcriptase Inhibitor, in Treatment-Naive HIV-Infected Participants. AIDS Res Hum Retroviruses. 2025 Jan;41(1):11-19. doi: 10.1089/AID.2023.0152. Epub 2024 Oct 3.
PubMed 39291814

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

All HIV-1 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK6186 in HIV-1 Infected Patients
ClinicalTrials.gov ID: NCT01152255
Acronym / sponsor ID: 6186-007
Conditions: HIV-1 Infection
Keywords: Treatment of HIV-1 Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 18 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 10 Oct 2010 (actual)
Primary completion: 30 Jun 2011 (actual)
Study completion: 30 Jun 2011 (actual)
First posted: 29 Jun 2010 (estimated)
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.

This study will evaluate the safety and tolerability of MK6186 and the change from baseline in plasma HIV-1 RNA after seven consecutive days of dosing.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Panel A - MK6186 40 mg	Experimental	Drug: MK6186MK6186 40 mg
Panel A - Placebo	Placebo comparator	Drug: Comparator: Placeboplacebo
Panel B - MK6186 150 mg	Experimental	Drug: MK6186MK6186 150 mg
Panel B - Placebo	Placebo comparator	Drug: Comparator: Placeboplacebo
Panel C - MK6186 <=150 mg	Experimental	Drug: MK6186MK6186 <=150 mg
Panel C - Placebo	Placebo comparator	Drug: Comparator: Placeboplacebo
Panel D - MK6186 <=150 mg	Experimental	Drug: MK6186MK6186 <=150 mg
Panel D - Placebo	Placebo comparator	Drug: Comparator: Placeboplacebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Other than HIV infection, patient's baseline health is judged to be stable
Patient is documented HIV-1 positive
Patient has not received an investigational agent or licensed ART with in the past 30 days

Key exclusion criteria (8 listed)

Patient has a history of stroke, chronic seizures, or major neurological disease
Patient has a history of cancer
Patient has used any immune therapy agents or immunosuppressive therapy within the past month
Patient requires or anticipates the use of any prescription or non-prescription drugs during the study
Patient has a current diagnosis of acute hepatitis, has a history of Hepatitis C or has positive Hepatitis B surface antigen

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
MK6186Panel A: 40 mg oral dose once daily for 7 days Panel B: 150 mg oral dose once daily for 7 days Panel C: Oral Dose <= 150 mg once daily for 7 days (dose level will be determined based on pharmacokinetic and pharmacodynamic results of panel A and B) Panel D: Oral Dose <= 150 mg once twice or three times daily for 7 days (dose level and dose frequency will be determined based on pharmacokinetic and pharmacodynamic results of panel A, B and C)	Drug	Panel A - MK6186 40 mg, Panel B - MK6186 150 mg, Panel C - MK6186 <=150 mg, Panel D - MK6186 <=150 mg
Comparator: PlaceboPlacebo tablets taken orally for seven day	Drug	Panel A - Placebo, Panel B - Placebo, Panel C - Placebo, Panel D - Placebo

Primary outcome

Change from baseline in plasma HIV-1 RNA
Time frame: Baseline and Day 7
Safety and tolerability of MK6186 measured by number of clinical and laboratory adverse experiences
Time frame: through Day 21

1 secondary outcome

C(24 hour) of MK6186
Time frame: Day 7

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
Results publication: PubMed 39291814Schurmann D, Huser A, Pfafflin F, Cilissen C, De Lepeleire I, Larson PJ, Anderson MS, Rizk ML, Hofmann J, Daumer M, Stegemann MS, Stoch SA, Wagner F, Iwamoto M. A Randomized, Double-Blind, Placebo-Controlled, Short-Term Monotherapy Study of MK-6186, an HIV-1 Non-Nucleoside Reverse Transcriptase Inhibitor, in Treatment-Naive HIV-Infected Participants. AIDS Res Hum Retroviruses. 2025 Jan;41(1):11-19. doi: 10.1089/AID.2023.0152. Epub 2024 Oct 3.

Related trials for HIV-1 Infection

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

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 Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK6186 in people with HIV-1 Infection, 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 23 Jul 2025. 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. 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 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?

The study was stopped early. Results are not available in the source record.

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 RNA (time frame: Baseline and Day 7). 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 NCT01152255, 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 23 Jul 2025.