A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)

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.

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Key information

Conditions

HIV-1 Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0518 (Raltegravir)

Drug

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.

Other names: Raltegravir

Famotidine

Drug

Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518

Omeprazole

Drug

20 mg oral tablet of omeprazole, once daily for 5 days

Primary outcomes

Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir

Time frame: 12 hours postdose

Area Under the Plasma Concentration-Time Curve and peak concentration

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, 3-Period, Fixed-Sequence Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 Pharmacokinetics in HIV-Infected Patients on a Stable MK0518-Containing Regimen

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Oct 23, 2009
Registry last updated: Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed