Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
This study will investigate the safety and efficacy of raltegravir as a therapy for Human Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral resistance.
Detailed Description
The primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir an...
Eligibility Criteria
Inclusion
- Patient must be HIV positive with HIV RNA values that are within ranges required by the study
- Patient must have documented failure of certain antiretroviral therapy
- Patient must be on the same antiretroviral therapy for at least the past two months
Exclusion
- Patient less than 16 years old
- Additional study criteria will be discussed and identified by the study doctor
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT00293254
Start Date
February 1 2006
End Date
May 1 2011
Last Update
March 21 2017
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