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
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 775
- Primary Endpoint
- Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Raltegravir 400 mg b.i.d.
Intervention: TRUVADA™ (Drug)
Raltegravir 800 mg q.d.
Intervention: TRUVADA™ (Drug)
Outcomes
Primary Outcomes
Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks
Time Frame: Week 48
Number of Participants With One or More Adverse Events at 48 Weeks
Time Frame: Week 48
Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks
Time Frame: Week 48
Secondary Outcomes
- 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)
- 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)
- Mean Change From Baseline to Week 96 in CD4 Cell Count(Baseline and Week 96)
- Number of Participants With One or More Adverse Events at 96 Weeks(Week 96)
- Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks(Week 96)