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: February 4, 2015

Last verified: February 2015

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Raltegravir Truvada Raltegravir potassium

U.S. FDA Resources

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

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, see Learn About Clinical Studies.

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):

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.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00745823 History of Changes
Other Study ID Numbers:	0518-071, 2008_543, CTRI/2009/091/000145
Study First Received:	September 2, 2008
Results First Received:	March 6, 2012
Last Updated:	February 4, 2015
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 February 27, 2015

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