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

Study Overview
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Brief Summary
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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
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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™.

Official Title
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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

Conditions
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HIV

Intervention / Treatment
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* Drug: Comparator: Raltegravir 400 mg b.i.d.
* Drug: Experimental: Raltegravir 800 mg q.d.
* Drug: TRUVADA™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Raltegravir 400 mg b.i.d.<br> | Drug: Comparator: Raltegravir 400 mg b.i.d.<br>* Raltegravir 400 mg tablet by mouth (PO) twice daily (b.i.d.) + two raltegravir placebo tablets + one tablet of TRUVADA™ once daily (q.d.)<br>* Other names: ISENTRESS™;Drug: TRUVADA™<br>* One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)<br>|
| Experimental: Raltegravir 800 mg q.d.<br> | Drug: Experimental: Raltegravir 800 mg q.d.<br>* Raltegravir 800 mg tablet PO q.d. + two raltegravir placebo tablets + one tablet TRUVADA™ q.d.<br>* Other names: ISENTRESS™;Drug: TRUVADA™<br>* One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks |  | 48 weeks | 
| 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 | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | Week 96 | 
| Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | Week 96 | 
| Mean Change From Baseline to Week 96 in CD4 Cell Count | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | Baseline and Week 96 | 
| Number of Participants With One or More Adverse Events at 96 Weeks | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | Week 96 | 
| Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks | As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed. | Week 96 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Infections, Treatment Naïve