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

This study has been terminated.
(Primary efficacy analysis at Week 48 did not demonstrate non-inferiority of raltegravir 800 mg once daily versus raltegravir 400 mg twice daily)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00745823
First received: September 2, 2008
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
HIV
Drug: Comparator: Raltegravir 400 mg b.i.d.
Drug: Experimental: Raltegravir 800 mg q.d.
Drug: TRUVADA™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Number of Participants With One or More Adverse Events at 48 Weeks [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 48 in CD4 Cell Count [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
  • Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.

  • Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.

  • Mean Change From Baseline to Week 96 in CD4 Cell Count [ Time Frame: Baseline and Week 96 ] [ Designated as safety issue: No ]
    As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.

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

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


Enrollment: 775
Study Start Date: September 2008
Study Completion Date: May 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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™.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745823

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional 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: MK-0518-071, 2008_543
Study First Received: September 2, 2008
Results First Received: March 6, 2012
Last Updated: May 14, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 20, 2014