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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

About this trial

This is an interventional treatment trial for HIV-1 Infection focused on measuring Treatment of HIV-1 Infection

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

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

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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