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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 because the information has not been verified recently.
Verified March 2014 by University of Roma La Sapienza.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Giancarlo Ceccarelli, University of Roma La Sapienza Identifier:
First received: March 28, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted

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
Drug: Atazanavir

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: January 2009
Estimated Study Completion Date: July 2014
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02102048

Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy)
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Principal Investigator: Vincenzo Vullo, MD University of Rome "Sapienza" (Italy)
  More Information

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

Keywords provided by University of Roma La Sapienza:
glucose metabolism
antiretroviral therapy

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on October 27, 2016