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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Giancarlo Ceccarelli, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT02102048
First received: March 28, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted

March 28, 2014
March 28, 2014
January 2009
March 2014   (final data collection date for primary outcome measure)
Homeostatis Model Assessment-Insulin Resistance (HOMA-IR) value [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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
Same as current
No Changes Posted
insulinemia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
difference between insulinemia value of patients that continue cART with LPV/r and patients that switch to ATV/r or ATV
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
Drug: Atazanavir
Other Name: Reyataz
  • Active Comparator: Atazanavir
    patients that switch cART to boosted or unboosted ATV
    Intervention: Drug: Atazanavir
  • No Intervention: other Protease Inibithors
    patients that continue the previous cART without changes.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
July 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT02102048
DPHID-UniRoma02
Yes
Giancarlo Ceccarelli, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Principal Investigator: Vincenzo Vullo, MD University of Rome "Sapienza" (Italy)
University of Roma La Sapienza
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP