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A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)

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ClinicalTrials.gov Identifier: NCT00745823
Recruitment Status : Terminated (Primary efficacy analysis at Week 48 did not demonstrate non-inferiority of raltegravir 800 mg once daily versus raltegravir 400 mg twice daily)
First Posted : September 3, 2008
Results First Posted : April 25, 2012
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared to twice daily raltegravir when each is given in combination with TRUVADA™ in treatment-naïve human immunodeficiency virus (HIV)-infected patients.

Condition or disease Intervention/treatment Phase
HIV Drug: Comparator: Raltegravir 400 mg b.i.d. Drug: Experimental: Raltegravir 800 mg q.d. Drug: TRUVADA™ Phase 3

Detailed Description:

Following the 96-week double-blind study period (MK0518-071)(NCT00745823), subjects may enroll in an extension study (MK0518-071-10)(NCT00745823). From weeks 96 to 120, subjects' treatment assignments will remain as in the base study.

From week 120 to 240, all subjects will receive open-label raltegravir (800 mg, once daily) in combination with TRUVADA™.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 775 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV Infected Patients
Study Start Date : September 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Raltegravir 400 mg b.i.d. Drug: Comparator: Raltegravir 400 mg b.i.d.
Raltegravir 400 mg tablet by mouth (PO) twice daily (b.i.d.) + two raltegravir placebo tablets + one tablet of TRUVADA™ once daily (q.d.)
Other Name: ISENTRESS™

Drug: TRUVADA™
One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
Experimental: Raltegravir 800 mg q.d. Drug: Experimental: Raltegravir 800 mg q.d.
Raltegravir 800 mg tablet PO q.d. + two raltegravir placebo tablets + one tablet TRUVADA™ q.d.
Other Name: ISENTRESS™

Drug: TRUVADA™
One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks [ Time Frame: Week 48 ]
  2. Number of Participants With One or More Adverse Events at 48 Weeks [ Time Frame: Week 48 ]
  3. Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks [ Time Frame: 48 weeks ]
  2. Mean Change From Baseline to Week 48 in CD4 Cell Count [ Time Frame: Baseline and Week 48 ]
  3. Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks [ Time Frame: Week 96 ]
    As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.

  4. Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks [ Time Frame: Week 96 ]
    As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.

  5. Mean Change From Baseline to Week 96 in CD4 Cell Count [ Time Frame: Baseline and Week 96 ]
    As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.

  6. Number of Participants With One or More Adverse Events at 96 Weeks [ Time Frame: Week 96 ]
    As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.

  7. Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks [ Time Frame: Week 96 ]
    As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is male or female 18 years of age or older
  • Patient is HIV positive
  • Patient is naïve to antiretroviral therapy (ART) or has received less than 7 days total of any ART

Extension Study:

  • The planned extension study did not take place as the study was terminated after the Week 48 analysis.

Exclusion Criteria:

  • Patient is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
  • Patient has documented resistance to tenofovir or emtricitabine
  • Patient is currently participating or has participated in a study with an investigational compound or device within 45 days of signing informed consent
  • Patient is pregnant or breastfeeding, or expecting to conceive
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745823


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00745823     History of Changes
Other Study ID Numbers: 0518-071
2008_543 ( Other Identifier: Merck Registration Number )
CTRI/2009/091/000145 ( Registry Identifier: CTRI )
First Posted: September 3, 2008    Key Record Dates
Results First Posted: April 25, 2012
Last Update Posted: March 21, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Keywords provided by Merck Sharp & Dohme Corp.:
HIV Infections
Treatment Naïve

Additional relevant MeSH terms:
Raltegravir Potassium
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
 HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors