NCT01152255

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2010

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

October 10, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2011

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

June 25, 2010

Last Update Submit

July 18, 2025

Conditions

HIV-1 Infection

Keywords

Treatment of HIV-1 Infection

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in plasma HIV-1 RNA

    Baseline and Day 7

  • Safety and tolerability of MK6186 measured by number of clinical and laboratory adverse experiences

    through Day 21

Secondary Outcomes (1)

  • C(24 hour) of MK6186

    Day 7

Study Arms (8)

Panel A - MK6186 40 mg

EXPERIMENTAL

MK6186 40 mg

Drug: MK6186

Panel A - Placebo

PLACEBO COMPARATOR

placebo

Drug: Comparator: Placebo

Panel B - MK6186 150 mg

EXPERIMENTAL

MK6186 150 mg

Drug: MK6186

Panel B - Placebo

PLACEBO COMPARATOR

placebo

Drug: Comparator: Placebo

Panel C - MK6186 <=150 mg

EXPERIMENTAL

MK6186 \<=150 mg

Drug: MK6186

Panel C - Placebo

PLACEBO COMPARATOR

placebo

Drug: Comparator: Placebo

Panel D - MK6186 <=150 mg

EXPERIMENTAL

MK6186 \<=150 mg

Drug: MK6186

Panel D - Placebo

PLACEBO COMPARATOR

placebo

Drug: Comparator: Placebo

Interventions

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)

Panel A - MK6186 40 mgPanel B - MK6186 150 mgPanel C - MK6186 <=150 mgPanel D - MK6186 <=150 mg
Comparator: PlaceboDRUG

Placebo tablets taken orally for seven day

Panel A - PlaceboPanel B - PlaceboPanel C - PlaceboPanel D - Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 39291814RESULT

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2010

First Posted

June 29, 2010

Study Start

October 10, 2010

Primary Completion

June 30, 2011

Study Completion

June 30, 2011

Last Updated

July 23, 2025

Record last verified: 2025-07