Conditions: HIV Infections
Keywords: HIV Kaletra Reyataz Insulin sensitivity Lipids Body Composition Receiving Kaletra Treatment Experienced
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15
Healthy volunteers: no

Brief summary:
To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat in HIV-infected patients.

Detailed description:
The primary objective of this study is to determine tissue specific glucose trafficking in patients before and after switching from a regimen containing Lopinavir/ritonavir (LPV/r) to one containing atazanavir/ritonavir (ATV/r). Secondary outcome measures of interest will include insulin sensitivity determined by clamp testing, and lipid metabolism and hepatic glucose production assessed using stable isotope techniques. We hypothesize that switching protease inhibitor (PI) to ATV/r from LPV/r will result in direct increases in glucose uptake in muscle and visceral adipose tissue in association with improvements in overall whole body insulin sensitivity compared to remaining on LPV/r. We will complete a prospective randomized trial of Human Immunodeficiency Virus (HIV) infected patients who have been on a stable antiretroviral (ARV) regimen containing LPV/r for at least 6 months and who will be randomized to either switch to a regimen containing ATV/r or remain on LPV/r for 6 months. Each subject will complete Positron Emission Tomography (PET) 18-fluorodeoxyglucose (FDG) imaging during a hyperinsulinemic clamp study at baseline and 6 months after randomization.

Arms:
arm 1: Boosted Reyataz (300mg atazanavir + 100mg ritonavir) arm 2: Kaletra (pre-study dose)

Interventions: intervention 1: atazanavir/ritonavir intervention 2: lopinavir/ritonavir
Intervention descriptions: intervention 1: atazanavir 300mg + ritonavir 100mg once daily intervention 2: patient remains on their pre-study dose of lopinavir/ritonavir

Protocol document: