Raltegravir Therapy for Women With HIV and Fat Accumulation
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
Phase 2
Details
Lead Sponsor:
University of California, Los Angeles
Collaborators:
Case Western Reserve University Merck Sharp & Dohme Corp. Tufts University University Health Network, Toronto Vanderbilt University Vanderbilt University Medical Center
Treatments:
HIV Protease Inhibitors Protease Inhibitors Raltegravir Potassium Reverse Transcriptase Inhibitors