Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)



Status:Recruiting
Conditions:HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:May 2014
End Date:March 2017
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects

To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily
in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with
TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being
tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir
400 mg twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion
of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL at Week 48.


Inclusion Criteria:

- HIV-1 positive

- Naïve to antiretroviral therapy including investigational antiretroviral agents

- Not of reproductive potential or, if of reproductive potential agrees to 1) true
abstinence, or 2) use of an acceptable method of birth control during the study

Exclusion Criteria:

- Use of recreational or illicit drugs or has recent history of drug or alcohol abuse
or dependence

- Has been treated for a viral infection other than HIV-1 (such as hepatitis B) with an
agent that is active against HIV-1 including but not limited to adefovir, tenofovir,
entecavir, emtricitabine, or lamivudine

- Has documented or known resistance to raltegravir, emtricitabine, and/or tenofovir
before the first dose of study drug

- Has participated in a study with an investigational compound or device within 30 days
or anticipates participating in such a study during this study

- Has used systemic immunosuppressive therapy or immune modulators within 30 days or is
anticipated to need them during the study (short courses of corticosteroids are
allowed)

- Requires or is anticipated to require any of the following prohibited medications
while in the study: phenobarbital, phenytoin, rifampin, rifabutin, or calcium,
magnesium and aluminum containing antacids, such as TUMS™, Maalox™ and Milk of
Magnesia™

- Has significant hypersensitivity or other contraindication to any of the components
of the study drugs

- Has current, active diagnosis of acute hepatitis due to any cause

- Is pregnant, breastfeeding, or expecting to conceive during the study

- Female participant expecting to donate eggs or male participant expecting to donate
sperm during the study

- Is or has a family member (spouse or children) who is investigational staff or
sponsor staff directly involved in this trial
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