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MK0518

Phase 1

HIV-1 Infection | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Mar 21, 2017

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

MK0518 · 1 trial · 2 indications

Phase 1 1
NCT01000818A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)HIV-1 Infection
COMPLETED18 Analytics
PHASE1COMPLETED
A Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 (Raltegravir) Pharmacokinetics in Human Immunodeficiency Virus (HIV)-Infected Patients (0518-054)
HIV-1 InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Area Under the Plasma Concentration-Time Curve and peak concentration

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Period 1EXPERIMENTALMK0518
Period 2EXPERIMENTALfamotidine + MK0518
Period 3EXPERIMENTALomeprazole + MK0518

Interventions

NameTypeDescription
MK0518 (Raltegravir)DRUG400 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.
famotidineDRUGSingle 20 mg famotidine oral tablet taken 2 hours prior to administration of AM dose of MK0518
omeprazoleDRUG20 mg oral tablet of omeprazole, once daily for 5 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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 metho...

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Frequently asked questions about MK0518

What is MK0518 used for?

MK0518 is an investigational small molecule being studied for the treatment of HIV infections and HIV-1 infection. It is being evaluated in HIV-infected patients, including those failing current antiretroviral therapies and treatment-naive patients, as part of combination therapy regimens.

Who makes MK0518?

MK0518 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in HIV-infected patients.

What phase is MK0518 in?

MK0518 is in Phase 3 clinical development. It has completed Phase 2 and Phase 3 trials, including a study comparing it to efavirenz in treatment-naive HIV-infected patients. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is MK0518 in?

MK0518 has been studied in several completed clinical trials, including NCT00100048 and NCT00105157 (Phase 2), NCT00369941 (Phase 3), and NCT01000818 (Phase 1). These trials evaluated its safety, efficacy, and pharmacokinetics in HIV-infected patients, with a total enrollment of 951 participants.

Is MK0518 the same as raltegravir?

MK0518 is also known as raltegravir. In clinical trials, it is referred to by both names, such as in NCT01000818, which evaluates the effect of famotidine and omeprazole on MK0518 (Raltegravir) pharmacokinetics in HIV-infected patients.

How does MK0518 work?

MK0518 is a small molecule being studied for HIV treatment. Its specific molecular target has not been disclosed in the available information, so its mechanism of action is not described here. Clinical trials focus on its safety and efficacy in HIV-infected patients.