ATAGLU: Study of Glucose Metabolism in HIV Positive Patients That Switch From Another Protease Inhibitor to Atazanavir

Not Applicable

• Conditions: HIV
• Interventions: Drug: Atazanavir

• Registration Number: NCT02102048
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-03-28
• Last Update Submitted: 2014-03-28
• Study First Posted: 2014-04-02
• Last Update Posted: 2014-04-02
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• HIV postive patients
• Patients on stable and effective antiretroviral therapy with a Protease Inhibitor

Exclusion Criteria

• use of Atazanavir before the enrolment
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atazanavir	Atazanavir	patients that switch cART to boosted or unboosted ATV

Primary Outcome Measures

Name	Time	Method
Homeostatis Model Assessment-Insulin Resistance (HOMA-IR) value	1 year	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

Secondary Outcome Measures

Name	Time	Method
insulinemia	1 year	difference between insulinemia value of patients that continue cART with LPV/r and patients that switch to ATV/r or ATV

Trial Locations

Locations (1)

Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy); 🇮🇹 Rome, Italy