Conditions: HIV Infections Lipodystrophy
Keywords: lipodystrophy fat visceral fat HIV women raltegravir ART anti HIV therapy NNRTI Protease inhibitor integrase inhibitor treatment experienced
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 39
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Immediate switch of PI or NNRTI to Raltegravir arm 2: Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir

Interventions: intervention 1: raltegravir
Intervention descriptions: intervention 1: raltegravir

Protocol document: