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

Phase 3TerminatedNCT00745823

Merck Sharp & Dohme LLC775 enrolled

Overview

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™.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

775

Conditions

HIV

Interventions

Comparator: Raltegravir 400 mg b.i.d.DRUG

Raltegravir 400 mg tablet by mouth (PO) twice daily (b.i.d.) + two raltegravir placebo tablets + one tablet of TRUVADA™ once daily (q.d.)

Experimental: Raltegravir 800 mg q.d.DRUG

Raltegravir 800 mg tablet PO q.d. + two raltegravir placebo tablets + one tablet TRUVADA™ q.d.

TRUVADA™DRUG

One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Time frame: 48 weeks

Mean Change From Baseline to Week 48 in CD4 Cell Count

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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