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

Phase 3

Terminated

• Conditions: HIV
• Interventions: Drug: TRUVADA™

• Registration Number: NCT00745823
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

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 Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Primary Completion: 2010-10
• Study Completion: 2011-05
• Disposition First Submitted: 2011-09-29
• Disposition First Submitted QC: 2011-09-29
• Disposition First Posted: 2011-10-05
• Results First Submitted: 2012-03-06
• Results First Submitted QC: 2012-03-30
• Results First Posted: 2012-04-25
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 775

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Raltegravir 400 mg b.i.d.	TRUVADA™	-
Raltegravir 800 mg q.d.	TRUVADA™	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks	Week 48
Number of Participants With One or More Adverse Events at 48 Weeks	Week 48
Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks	Week 48

Secondary Outcome Measures

Name	Time	Method
Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks	48 weeks
Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks	Week 96	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 48 in CD4 Cell Count	Baseline and Week 48
Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks	Week 96	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	Baseline and Week 96	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	Week 96	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	Week 96	As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.