HIV Infections
Conditions
Keywords
Antivirals / HIV
Brief summary
The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300 mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without raltegravir 400 mg BID.
Interventions
DRUGRaltegravir
Tablet, Oral, 400 mg, twice daily for 5 Days
DRUGAtazanavir
Capsule, Oral, 300 mg, twice daily for 7 Days
DRUGAtazanavir + Raltegravir
Capsule/Tablet, Oral, 300/400, twice daily for 14 Days
Sponsors
Merck Sharp & Dohme LLC
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m² * Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test
Exclusion criteria
* Any significant acute or chronic medical illness * Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations. * Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration * Use of any other drugs, including over-the-counter medications and herbal preparations within 1 week prior to study drug administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Assessments | Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge |
| Pharmacokinetic Assessments | Days 5, 12, and 26 |
Countries
United States
Outcome results
None listed