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)

Last updated: January 11, 2019
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

3

Condition

Aids And Aids Related Infections

Hiv Infections

Hiv/aids

Treatment

N/A

Clinical Study ID

NCT02131233
0518-292
2013-001939-47
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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) trueabstinence, or 2) use of an acceptable method of birth control during the study

Exclusion

Exclusion Criteria:

  • Use of recreational or illicit drugs or has recent history of drug or alcohol abuse ordependence

  • Has been treated for a viral infection other than HIV-1 (such as hepatitis B) with anagent 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 tenofovirbefore the first dose of study drug

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

  • Has used systemic immunosuppressive therapy or immune modulators within 30 days or isanticipated to need them during the study (short courses of corticosteroids areallowed)

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

  • Has significant hypersensitivity or other contraindication to any of the components ofthe 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 donatesperm during the study

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

Study Design

Total Participants: 802
Study Start date:
May 23, 2014
Estimated Completion Date:
December 19, 2016

Connect with a study center

  • Merck Sharp & Dohme (Argentina) Inc.

    Buenos Aires,
    Argentina

    Site Not Available

  • Merck Sharp & Dohme

    North Ryde,
    Australia

    Site Not Available

  • MSD Belgium BVBA/SPRL

    Brussels,
    Belgium

    Site Not Available

  • Merck Canada

    Kirkland, Quebec H9H 3L1
    Canada

    Site Not Available

  • Merck Sharp & Dohme (I.A.) Corp.

    Santiago,
    Chile

    Site Not Available

  • MDS Colombia SAS

    Bogota,
    Colombia

    Site Not Available

  • MSD France

    Paris,
    France

    Site Not Available

  • Merck Sharp & Dohme GmbH

    Haar,
    Germany

    Site Not Available

  • MSD CARD

    Guatemala,
    Guatemala

    Site Not Available

  • MSD Ireland (Human Health) Ltd.

    Dublin,
    Ireland

    Site Not Available

  • Merck Sharp & Dohme Co. Ltd.

    Hod Hasharon,
    Israel

    Site Not Available

  • MSD Italia S.r.l.

    Rome,
    Italy

    Site Not Available

  • MSD Korea LTD

    Seoul,
    Korea, Republic of

    Site Not Available

  • MSD

    Petaling Jaya,
    Malaysia

    Site Not Available

  • Merck Sharp & Dohme, Peru S.R.L.

    Lima,
    Peru

    Site Not Available

  • Merck Sharp & Dohme (I.A.) Corporation

    Makati,
    Philippines

    Site Not Available

  • Merck Sharp & Dohme Lda.

    Paco D'arcos,
    Portugal

    Site Not Available

  • Call for Information (Investigational Site 0184)

    San Juan, 00935
    Puerto Rico

    Site Not Available

  • Merck Sharp & Dohme IDEA, Inc.

    Moscow,
    Russian Federation

    Site Not Available

  • MSD (Pty) LTD South Africa

    Midrand,
    South Africa

    Site Not Available

  • Merck Sharp and Dohme de Espana S.A.

    Madrid,
    Spain

    Site Not Available

  • MSD International GmbH

    Lucerne 6,
    Switzerland

    Site Not Available

  • Merck Sharp & Dohme (I.A.) Corp.

    Taipei,
    Taiwan

    Site Not Available

  • MSD (Thailand) Ltd.

    Bangkok,
    Thailand

    Site Not Available

  • Merck Sharp & Dohme Ltd.

    Hoddesdon,
    United Kingdom

    Site Not Available

  • Call for Information (Investigational Site 0288)

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Call for Information (Investigational Site 0173)

    Beverly Hills, California 90211
    United States

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  • Call for Information (Investigational Site 0133)

    Los Angeles, California 90036
    United States

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    Sacramento, California 95811
    United States

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    Washington, District of Columbia 20009
    United States

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    Hialeah, Florida 33012
    United States

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  • Call for Information (Investigational Site 0168)

    Miami, Florida 33169
    United States

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  • Call for Information (Investigational Site 0162)

    Orlando, Florida 32803
    United States

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  • Call for Information (Investigational Site 0157)

    Savannah, Georgia 31401
    United States

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    Chicago, Illinois 60612
    United States

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    Indianapolis, Indiana 46202
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    Wichita, Kansas 67214
    United States

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    Boston, Massachusetts 02215
    United States

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  • Call for Information (Investigational Site 0146)

    Kansas City, Missouri 64111
    United States

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  • Call for Information (Investigational Site 0165)

    Saint Louis, Missouri 63139
    United States

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  • Call for Information (Investigational Site 0127)

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Call for Information (Investigational Site 0129)

    Santa Fe, New Mexico 87505
    United States

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  • Call for Information (Investigational Site 0140)

    Buffalo, New York 14215
    United States

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  • Call for Information (Investigational Site 0137)

    Rochester, New York 14642
    United States

    Site Not Available

  • Call for Information (Investigational Site 0147)

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Call for Information (Investigational Site 0143)

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Call for Information (Investigational Site 0290)

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Call for Information (Investigational Site 0142)

    Providence, Rhode Island 02904
    United States

    Site Not Available

  • Call for Information (Investigational Site 0158)

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Call for Information (Investigational Site 0163)

    Dallas, Texas 75246
    United States

    Site Not Available

  • Call for Information (Investigational Site 0160)

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Call for Information (Investigational Site 0156)

    Houston, Texas 77098
    United States

    Site Not Available

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