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

HIV Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00745823
• Other study ID #: 0518-071
• Secondary ID: 2008_543CTRI/200
• Status: Terminated
• Phase: Phase 3
• First received: September 2, 2008
• Last updated: February 14, 2017
• Start date: September 2008
• Est. completion date: May 2011

Study information

• Verified date: February 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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™.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 775
• Est. completion date: May 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Comparator: Raltegravir 400 mg b.i.d.
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.
Raltegravir 800 mg tablet PO q.d. + two raltegravir placebo tablets + one tablet TRUVADA™ q.d.
• TRUVADA™
One tablet TRUVADA™ q.d. (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks		Week 48
Primary	Number of Participants With One or More Adverse Events at 48 Weeks		Week 48
Primary	Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks		Week 48
Secondary	Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks		48 weeks
Secondary	Mean Change From Baseline to Week 48 in CD4 Cell Count		Baseline and Week 48
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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