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

NCT ID: NCT02102048

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-07-31

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.

Conditions

HIV

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atazanavir

patients that switch cART to boosted or unboosted ATV

Group Type: ACTIVE_COMPARATOR

Atazanavir

Intervention Type: DRUG

other Protease Inibithors

patients that continue the previous cART without changes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Atazanavir

Intervention Type: DRUG

Other Intervention Names

Reyataz

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Giancarlo Ceccarelli

MD, PhD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincenzo Vullo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rome "Sapienza" (Italy)

Locations

Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy)

Rome, , Italy

Countries

Italy

Other Identifiers

DPHID-UniRoma02

Identifier Type: -

Identifier Source: org_study_id