Carolinas HealthCare System

Research and Clinical Trials

Title   QUAD 0103
Brief Description   With an estimated 33.2 million people in the world infected with the virus, human immunodeficiency virus (HIV) is a major medical problem.

The purpose of this study is to see if the investigational compound of elvitegravir/emtricitabine/tenofovir/cobicistat (EVG/FTC/TDF/GS-9350) is safe and effective in reducing levels of HIV in the blood of subjects who are treatment-naïve (those who have not received any antiretroviral medication).
Who may be Eligible   Inclusion criteria includes no history of prior antiretroviral therapy, viral load >5,000, normal ECG, glomerular filtration rate >70, adequate hematologic function, AST/ALT < 5 times upper limites of normal, adequate contraception for females and males of childbearing potential, age greater or equal to 18, and life expectancy greater than or equal to one year.

Exclusion criteria includes a new AIDS defining condition diagnosed within 30 days of screening, anyone receiving/expected to receive Hep C drug treatment, cirrhosis, subjects with implanted defibrillators or pacemakers, a history of malignancy in the last 5 years (excluding Kaposi Sarcoma, basal cell carcinoma or noninvasive cutaneous squamous carcinoma), use of disallowed concomittant medications, and alcohol or substance abuse that would interfere with study compliance.
Specialty/Disorder   HIV
IRB Number   CHS1-10-148
Principal Investigator   Johnson, Marc
For More Information, Contact   Jessica  A.  Kearney-Bryan , RN
Phone:  (704) 355-0244  Fax:  (704) 446-7641 
Address:  3rd Floor
Myers Park Clinic
1350 South King's Drive
Charlotte, NC 28207
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