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Research and Clinical Trials

Title  
A Multicenter Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Rltonavir-Boosted Elvitegravir (EVGIr) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment
Brief Description  
The purpose of this study is to evaluate the experimental drug elvitegravir which is one of a new class of anti-HIV medications called integrase inhibitors. The study will attempt to determine if elvitegravir is safe and effective when given in combination with the background regimen (the other antiviral medications that a patient may currently be taking or will take to participate in the study), in subjects who are failing their current regimen of HIV medications. The safety and effectivene
Who may be Eligible  
Inclusion criteria include:HIV viral load > 1,000, documented antiretroviral resistance, stable antiretroviral regimen 30 days prior to screening, normal ECG adequate renal function, adequate hematologic function, hepatic transaminases < 5 times upper limit of normal, negative serum pregnancy test, agreement to utilize highly effective contraception should subject be of childbearing potential, age > 1 8 years, life expectancy > 1 year, the ability to understand a written informed consent. Exclusion criteria include: a new AIDS defining condition within 30 days of Screening, prior treatment with an integrase inhibitor, ascites, encephalopathy, females who are pregnant or breastfeeding, alcohol/substance abuse that could interefere with compliance a history of or ongoing malignancy, an active/serious infection that requires parental therapy within 30 days of Baseline, participation in any other clinical trial, or a known hypersensitivity to the study drugs.
Speciality/Disorder  
HIV
IRB Number  
CHS1-08-427
Principal Investigator  
Horton, James

For More Information, Contact  Moriah  M, Rogers
Phone:  (704) 446-1642  Fax:  (704) 446-1642  
Email:  moriah.rogers@carolinashealthcare.org
Address:1350 S. Kings Drive Charlotte, NC 28207
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