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
  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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
HIV
diabetes
glucose metabolism
antiretroviral therapy
ritonavir
atazanavir

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
Protease Inhibitors
Atazanavir
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014