Status:
TERMINATED
A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 immunod...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
775 Patients enrolled
Trial Details
Trial ID
NCT00745823
Start Date
September 1 2008
End Date
May 1 2011
Last Update
March 21 2017
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