Ritonavir-boosted protease inhibitor (PI) regimens have become a backbone for treatment of people with HIV. However, adverse drug effects, particularly lipodystrophy/lipoatrophy are closely associated with these regimens. Therefore, there is a need for a drug with comparable effectiveness to the ritonavir boosted PIs without the side effects of dyslipidemia, which has been associated with elevated cholesterol and cardiovascular disease Raltegravir is an HIV integrase inhibitor in phase III clinical development. To date there are no approved drugs that target the same stage of the HIV-1 lifecycle. However, data from studies indicate that raltegravir is generally safe and well tolerated and has strong antiretroviral activity when used in combination with licensed antiretroviral medications. This study aims to demonstrate that patients substituting raltegravir for a PI or NNRTI based antiretroviral regimen will be associated with a 10% reduction in body fat over 24 weeks. The study will consist of a total of 10 subject visits over a period of 48 weeks. Approximately 40 female patients will participate in this study (approximately 10 at UCLA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
raltegravir
UCLA CARE Center
Los Angeles, California, United States
Tufts University School of Medicine
Boston, Massachusetts, United States
Case School of Medicine
Cleveland, Ohio, United States
Vanderbilt University
Nashville, Tennessee, United States
University Health Network, Toronto
Toronto, Ontario, Canada
Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2)
Adipose tissue volumes were measured via single slice L4-L5 CT scan, and volumes were calculated using cm\^2, not cm\^3, as is standard protocol at the Tufts University Body Composition Reading Center. The authors acknowledge that cm\^2 uses area as a surrogate for volume, but this protocol is well-accepted in our field.
Time frame: Baseline and 24 weeks
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