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

Primary Purpose

HIV

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Atazanavir

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV, diabetes, glucose metabolism, antiretroviral therapy, ritonavir, atazanavir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Atazanavir

other Protease Inibithors

Arm Description

patients that switch cART to boosted or unboosted ATV

patients that continue the previous cART without changes.

Outcomes

Primary Outcome Measures

Homeostatis Model Assessment-Insulin Resistance (HOMA-IR) value

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

insulinemia

difference between insulinemia value of patients that continue cART with LPV/r and patients that switch to ATV/r or ATV

Full Information

NCT ID

NCT02102048

First Posted

March 28, 2014

Last Updated

March 28, 2014

Sponsor

University of Roma La Sapienza

1. Study Identification

Unique Protocol Identification Number

NCT02102048

Brief Title

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

Acronym

ATAGLU

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2009 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Roma La Sapienza

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Atazanavir

Arm Type

Active Comparator

Arm Description

patients that switch cART to boosted or unboosted ATV

Arm Title

other Protease Inibithors

Arm Type

No Intervention

Arm Description

patients that continue the previous cART without changes.

Intervention Type

Drug

Intervention Name(s)

Atazanavir

Other Intervention Name(s)

Reyataz

Primary Outcome Measure Information:

Title

Homeostatis Model Assessment-Insulin Resistance (HOMA-IR) value

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

insulinemia

Description

difference between insulinemia value of patients that continue cART with LPV/r and patients that switch to ATV/r or ATV

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vincenzo Vullo, MD

Organizational Affiliation

University of Rome "Sapienza" (Italy)

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Rome

ZIP/Postal Code

00161

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

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