MK6186 in HIV-1 Infected Patients (MK-6186-007 AM2)
- Registration Number
- NCT01152255
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Panel C - MK6186 <=150 mg MK6186 MK6186 \<=150 mg Panel B - MK6186 150 mg MK6186 MK6186 150 mg Panel A - MK6186 40 mg MK6186 MK6186 40 mg Panel D - MK6186 <=150 mg MK6186 MK6186 \<=150 mg
- Primary Outcome Measures
Name Time Method 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
Name Time Method C(24 hour) of MK6186 Day 7