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

NCT02102048 | Unknown DMC

• 1 other identifier: DPHID-UniRoma02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (1)

• insulinemia

  1 year

Study Arms (2)

Atazanavir

ACTIVE COMPARATOR

patients that switch cART to boosted or unboosted ATV

Drug: Atazanavir

other Protease Inibithors

NO INTERVENTION

patients that continue the previous cART without changes.

Interventions

Atazanavir DRUG

Also known as: Reyataz

Atazanavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV postive patients
• Patients on stable and effective antiretroviral therapy with a Protease Inhibitor

You may not qualify if:

• use of Atazanavir before the enrolment
• pregnancy

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

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

Rome, 00161, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Atazanavir Sulfate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Vincenzo Vullo, MD

  University of Rome "Sapienza" (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, MSc

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 2, 2014
• Study Start: January 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 2, 2014

Record last verified: 2014-03

Locations

IT (1)