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

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Raltegravir Potassium

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