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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: October 27, 2014
Last verified: October 2014

September 2, 2008
October 27, 2014
September 2008
October 2010   (final data collection date for primary outcome measure)
  • 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 ]
HIV RNA <50 copies/ml, evaluation of safety and tolerability [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00745823 on ClinicalTrials.gov Archive Site
  • 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.
HIV RNA <50 copies/ml, evaluation of safety and tolerability [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)
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

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.

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™.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
HIV
  • 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: 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)
  • Active Comparator: Raltegravir 400 mg b.i.d.
    Interventions:
    • Drug: Comparator: Raltegravir 400 mg b.i.d.
    • Drug: TRUVADA™
  • Experimental: Raltegravir 800 mg q.d.
    Interventions:
    • Drug: Experimental: Raltegravir 800 mg q.d.
    • Drug: TRUVADA™
Eron JJ Jr, Rockstroh JK, Reynes J, Andrade-Villanueva J, Ramalho-Madruga JV, Bekker LG, Young B, Katlama C, Gatell-Artigas JM, Arribas JR, Nelson M, Campbell H, Zhao J, Rodgers AJ, Rizk ML, Wenning L, Miller MD, Hazuda D, DiNubile MJ, Leavitt R, Isaacs R, Robertson MN, Sklar P, Nguyen BY; QDMRK Investigators. Raltegravir once daily or twice daily in previously untreated patients with HIV-1: a randomised, active-controlled, phase 3 non-inferiority trial. Lancet Infect Dis. 2011 Dec;11(12):907-15. doi: 10.1016/S1473-3099(11)70196-7. Epub 2011 Sep 18. Erratum in: Lancet Infect Dis. 2011 Dec;11(12):895. Dosage error in article text.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
775
May 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00745823
0518-071, 2008_543, CTRI/2009/091/000145
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP