ATAGLU: Study of Glucose Metabolism in HIV Positive Patients That Switch From Another Protease Inhibitor to 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||ATAGLU: Study of Glucose Metabolism in HIV Positive Patients That Switch From Another Protease Inhibitor to Boosted or Unboosted Atazanavir|
- Homeostatis Model Assessment-Insulin Resistance (HOMA-IR) value [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]difference between Homeostatis Model Assessment-Insulin Resistance (HOMA-IR) value of patients that continue cART with LPV/r and patients that switch to ATV/r or ATV
- insulinemia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]difference between insulinemia value of patients that continue cART with LPV/r and patients that switch to ATV/r or ATV
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||July 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Atazanavir
patients that switch cART to boosted or unboosted ATV
Other Name: Reyataz
No Intervention: other Protease Inibithors
patients that continue the previous cART without changes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02102048
|Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy)|
|Rome, Italy, 00161|
|Principal Investigator:||Vincenzo Vullo, MD||University of Rome "Sapienza" (Italy)|