HIV Clinical Trial
Official title:
ATAGLU: Study of Glucose Metabolism in HIV Positive Patients That Switch From Another Protease Inhibitor to Boosted or Unboosted Atazanavir
The association between HIV infection , insulin resistance and diabetes mellitus is the
topic of many studies that have attempted to analyze the problem from different points of
view. In fact, the risk of insulin resistance in HIV-positive patients on antiretroviral
therapy seems to depend not only on the same factors that determine its incidence in the
general population , but also on the effects of antiretroviral therapy on glucose
metabolism. To confirm this observation, studies that have evaluated the incidence of
diabetes in patients with HIV infection on antiretroviral therapy have shown that the
incidence of diabetes in infected individuals is significantly higher than that observed in
the uninfected population. Moreover others preliminar stadies observed that protease
inhibitors may induce hyperglycemia and diabetes mellitus. Anyway at this moment no large
data are available that indicate the utility to modify the antiretroviral therapy in HIV
positive patients with a damage of glucose metabolism.
ATAGLU is a cohort composed by HIV positive patients in effective and stable combined
antiretroviral therapy (cART) with undetectable viral load. All patients studied had carried
out a therapy with Lopinavir/Ritonavir (LPV/r) + optimal backbone therapy (OBT) and then in
part switch to Atazanavir (ATV) + OBT or Atazanavir/ritonavir (ATV/r) + OBT , in part
continue with LPV/r + OBT .
The objective was to characterize the changes of carbohydrate profile of a cohort of
patients who made a switch from a regimen with LPV/r to boosted or unboosted ATV.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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