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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01000818
First received: October 22, 2009
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
HIV Infections
Drug: MK0518 (Raltegravir)
Drug: famotidine
Drug: omeprazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir [ Time Frame: 12 hours postdose ] [ Designated as safety issue: No ]
    Area Under the Plasma Concentration-Time Curve and peak concentration


Enrollment: 18
Study Start Date: June 2008
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Period 1
MK0518
Drug: MK0518 (Raltegravir)
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 Name: Raltegravir
Experimental: Period 2
famotidine + MK0518
Drug: MK0518 (Raltegravir)
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 Name: Raltegravir
Drug: famotidine
Single 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518
Experimental: Period 3
omeprazole + MK0518
Drug: MK0518 (Raltegravir)
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 Name: Raltegravir
Drug: omeprazole
20 mg oral tablet of omeprazole, once daily for 5 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000818

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01000818     History of Changes
Other Study ID Numbers: 0518-054, MK0518-054, 2009_681
Study First Received: October 22, 2009
Results First Received: March 10, 2010
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Treatment experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Famotidine
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014