Clinical Trials

MainTitle

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

The recruitment status of this study is unknown.

Verified March 2014

Sponsor
University of Roma La Sapienza


Information provided by (Responsible Party)
Giancarlo Ceccarelli, University of Roma La Sapienza

ClinicalTrials.gov Identifier
NCT02102048

First received: March 28, 2014
Last updated: March 28, 2014
Last Verified: March 2014
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV

Drug : Atazanavir

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Further study details as provided by Giancarlo Ceccarelli, University of Roma La Sapienza:

Primary Outcome Measures

  • Homeostatis Model Assessment-Insulin Resistance (HOMA-IR) value [ Time Frame: 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:
  • insulinemia [ Time Frame: 1 year ]
    difference between insulinemia value of patients that continue cART with LPV/r and patients that switch to ATV/r or ATV

Estimated Enrollment: 300
Study Start Date: January 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Atazanavir
patients that switch cART to boosted or unboosted ATV
Drug: Atazanavir
Other Name: Reyataz
No Intervention: other Protease Inibithors
patients that continue the previous cART without changes.
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102048

Locations

Italy
Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy)
Rome, Italy, 00161

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

Principal Investigator: Vincenzo Vullo, MD University of Rome "Sapienza" (Italy)
More Information

More Information


Responsible Party: Giancarlo Ceccarelli, MD, PhD, MSc, University of Roma La Sapienza  
ClinicalTrials.gov Identifier: NCT02102048   History of Changes  
Other Study ID Numbers: DPHID-UniRoma02  
Study First Received: March 28, 2014  
Last Updated: March 28, 2014  

Keywords provided by Giancarlo Ceccarelli, University of Roma La Sapienza:

HIV
diabetes
glucose metabolism
antiretroviral therapy
ritonavir
atazanavir

Additional relevant MeSH terms:
HIV Seropositivity
Atazanavir Sulfate

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.