Phase 1
Completed N=18
A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)
Source: ClinicalTrials.gov NCT01000818 ↗Enrolled (actual)
18
Serious AEs
1.4%
Results posted
May 2010
Primary outcomePrimary: Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir — 12.36; 17.95; 17.12 µM*hr
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir |
12.36; 17.95; 17.12 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01000818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.