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

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.

Study Overview

• Status: Terminated
• Conditions: HIV-1 Infection
• Intervention / Treatment: Drug: MK6186; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panel A - MK6186 40 mg; MK6186 40 mg	Drug: MK6186; 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)
Placebo Comparator: Panel A - Placebo; placebo	Drug: Comparator: Placebo; Placebo tablets taken orally for seven day
Experimental: Panel B - MK6186 150 mg; MK6186 150 mg	Drug: MK6186; 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)
Placebo Comparator: Panel B - Placebo; placebo	Drug: Comparator: Placebo; Placebo tablets taken orally for seven day
Experimental: Panel C - MK6186 <=150 mg; MK6186 <=150 mg	Drug: MK6186; 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)
Placebo Comparator: Panel C - Placebo; placebo	Drug: Comparator: Placebo; Placebo tablets taken orally for seven day
Experimental: Panel D - MK6186 <=150 mg; MK6186 <=150 mg	Drug: MK6186; 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)
Placebo Comparator: Panel D - Placebo; placebo	Drug: Comparator: Placebo; Placebo tablets taken orally for seven day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
C(24 hour) of MK6186	Day 7

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 25, 2010
• First Submitted That Met QC Criteria: June 28, 2010
• First Posted (Estimate): June 29, 2010

Study Record Updates

• Last Update Posted (Estimate): October 19, 2015
• Last Update Submitted That Met QC Criteria: October 16, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Treatment of HIV-1 Infection
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 6186-007; 2010_542