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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-10

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV-1 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Panel A - MK6186 40 mg

MK6186 40 mg

Group Type EXPERIMENTAL

MK6186

Intervention Type DRUG

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 - Placebo

placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Placebo tablets taken orally for seven day

Panel B - MK6186 150 mg

MK6186 150 mg

Group Type EXPERIMENTAL

MK6186

Intervention Type DRUG

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 B - Placebo

placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Placebo tablets taken orally for seven day

Panel C - MK6186 <=150 mg

MK6186 \<=150 mg

Group Type EXPERIMENTAL

MK6186

Intervention Type DRUG

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 C - Placebo

placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Placebo tablets taken orally for seven day

Panel D - MK6186 <=150 mg

MK6186 \<=150 mg

Group Type EXPERIMENTAL

MK6186

Intervention Type DRUG

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 D - Placebo

placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Placebo tablets taken orally for seven day

Interventions

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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)

Intervention Type DRUG

Comparator: Placebo

Placebo tablets taken orally for seven day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No