MK6186 in HIV-1 Infected Patients (MK-6186-007 AM2)
Primary Purpose
HIV-1 Infection
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK6186
Comparator: Placebo
Sponsored by
About this trial
This is an interventional treatment trial for HIV-1 Infection focused on measuring Treatment of HIV-1 Infection
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Panel A - MK6186 40 mg
Panel A - Placebo
Panel B - MK6186 150 mg
Panel B - Placebo
Panel C - MK6186 <=150 mg
Panel C - Placebo
Panel D - MK6186 <=150 mg
Panel D - Placebo
Arm Description
MK6186 40 mg
placebo
MK6186 150 mg
placebo
MK6186 <=150 mg
placebo
MK6186 <=150 mg
placebo
Outcomes
Primary Outcome Measures
Change from baseline in plasma HIV-1 RNA
Safety and tolerability of MK6186 measured by number of clinical and laboratory adverse experiences
Secondary Outcome Measures
C(24 hour) of MK6186
Full Information
NCT ID
NCT01152255
First Posted
June 25, 2010
Last Updated
October 16, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01152255
Brief Title
MK6186 in HIV-1 Infected Patients (MK-6186-007 AM2)
Official Title
A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK6186 in HIV-1 Infected Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection
Keywords
Treatment of HIV-1 Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Panel A - MK6186 40 mg
Arm Type
Experimental
Arm Description
MK6186 40 mg
Arm Title
Panel A - Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
Panel B - MK6186 150 mg
Arm Type
Experimental
Arm Description
MK6186 150 mg
Arm Title
Panel B - Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
Panel C - MK6186 <=150 mg
Arm Type
Experimental
Arm Description
MK6186 <=150 mg
Arm Title
Panel C - Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
Panel D - MK6186 <=150 mg
Arm Type
Experimental
Arm Description
MK6186 <=150 mg
Arm Title
Panel D - Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
MK6186
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
Placebo tablets taken orally for seven day
Primary Outcome Measure Information:
Title
Change from baseline in plasma HIV-1 RNA
Time Frame
Baseline and Day 7
Title
Safety and tolerability of MK6186 measured by number of clinical and laboratory adverse experiences
Time Frame
through Day 21
Secondary Outcome Measure Information:
Title
C(24 hour) of MK6186
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
MK6186 in HIV-1 Infected Patients (MK-6186-007 AM2)
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