HIV-1 Infection
Conditions
Keywords
Treatment of HIV-1 Infection
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.
Interventions
DRUGMK6186
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)
DRUGComparator: Placebo
Placebo tablets taken orally for seven day
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| C(24 hour) of MK6186 | Day 7 |
Outcome results
None listed