Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02102048
Acronym
ATAGLU
Enrollment
300
Registered
2014-04-02
Start date
2009-01-31
Completion date
2014-07-31
Last updated
2014-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, diabetes, glucose metabolism, antiretroviral therapy, ritonavir, atazanavir

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.

Interventions

DRUGAtazanavir

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Homeostatis Model Assessment-Insulin Resistance (HOMA-IR) value1 yeardifference 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

MeasureTime frameDescription
insulinemia1 yeardifference between insulinemia value of patients that continue cART with LPV/r and patients that switch to ATV/r or ATV

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026