Clinical trial NCT00745823: A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: HIV
Keywords: HIV Infections
Treatment Naïve
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 775
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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™.

Eligibility 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

Primary outcomes:
measure: Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks
timeFrame: Week 48
measure: Number of Participants With One or More Adverse Events at 48 Weeks
timeFrame: Week 48
measure: Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks
timeFrame: Week 48
Secondary outcomes:
measure: Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks
timeFrame: 48 weeks
measure: Mean Change From Baseline to Week 48 in CD4 Cell Count
timeFrame: Baseline and Week 48
measure: Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks
timeFrame: Week 96
measure: Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks
timeFrame: Week 96
measure: Mean Change From Baseline to Week 96 in CD4 Cell Count
timeFrame: Baseline and Week 96
measure: Number of Participants With One or More Adverse Events at 96 Weeks
timeFrame: Week 96
measure: Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks
timeFrame: Week 96
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.