HIV-1 Infection, HIV Infections
Conditions
Keywords
Treatment experienced
Brief summary
An open-label, 3-period, fixed-sequence study in a panel of 18 HIV-infected patients on MK0518 as part of a stable treatment regimen for HIV.
Interventions
400 mg oral tablet of MK0518 once every 12 hours. Period 1 duration is one day, Period 2 duration is one day, Period 3 duration is five days.
DRUGfamotidine
Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518
DRUGomeprazole
20 mg oral tablet of omeprazole, once daily for 5 days
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is Human immunodeficiency virus (HIV) positive * Patient is taking an MK0518 (Raltegravir) containing regimen * Patient has not had any changes to his/her antiviral regimen in the last 2 weeks * Patient who is of reproductive potential agrees to use an acceptable method of birth control * Patients baseline health is stable
Exclusion criteria
* Patient has a history of stroke or chronic seizures. * Patient has a history of gastric bypass surgery * Patient is pregnant of breastfeeding * Patient consumes excessive amounts of caffeinated beverages daily * Patient has had major surgery, donated blood, or participated in another investigational study in the past 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir | 12 hours postdose | Area Under the Plasma Concentration-Time Curve and peak concentration |
Participant flow
Recruitment details
Participants were recruited through Abbott Northwestern Hospital Infectious Diseases Clinic, Minneapolis, MN and Prism Research, St. Paul, MN, between June 2008 and March 2009.
Pre-assignment details
A total of 18 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Raltegravir/Famotidine/Omeprazole Period 1 - 400 mg Raltegravir x 1 day
Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day
Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Raltegravir/Famotidine/Omeprazole |
|---|---|
| Age, Continuous | 49.3 years |
| Height | 176.6 Centimeters |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 16 Participants |
| Weight | 85.7 Kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 2 / 18 | 1 / 18 | 6 / 18 |
| serious Total, serious adverse events | 1 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir
Area Under the Plasma Concentration-Time Curve and peak concentration
Time frame: 12 hours postdose
Population: Eighteen HIV-Infected Patients
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 400 mg Raltegravir | Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir | 12.36 µM*hr |
| 20 mg Famotidine + 400 mg Raltegravir | Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir | 17.95 µM*hr |
| 20 mg Omeprazole + 400 mg Raltegravir | Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir | 17.12 µM*hr |
95% CI: [1.04, 1.84]
95% CI: [1.09, 1.93]