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

NCT01000818 | Completed Phase 1 Results

• 3 other identifiers: 0518-054MK0518-0542009_681
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV-1 Infection; HIV Infections

Keywords

Treatment experienced

Outcome Measures

Primary Outcomes (1)

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

  Area Under the Plasma Concentration-Time Curve and peak concentration

  12 hours postdose

Study Arms (3)

Period 1

EXPERIMENTAL

MK0518

Drug: MK0518 (Raltegravir)

Period 2

EXPERIMENTAL

famotidine + MK0518

Drug: MK0518 (Raltegravir); Drug: famotidine

Period 3

EXPERIMENTAL

omeprazole + MK0518

Drug: MK0518 (Raltegravir); Drug: omeprazole

Interventions

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.

Also known as: Raltegravir

Period 1; Period 2; Period 3

famotidine DRUG

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

Period 2

omeprazole DRUG

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

Period 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium; Famotidine; Omeprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: June 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 21, 2017
• Results First Posted: May 28, 2010

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share