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

Study Overview
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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.

Official Title
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A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK6186 in HIV-1 Infected Patients

Conditions
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HIV-1 Infection

Intervention / Treatment
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* Drug: MK6186
* Drug: Comparator: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of HIV-1 Infection