NCT00483392

Brief Summary

The purpose of this study is to evaluate and compare the effects of treatment with rosiglitazone and metformin on insulin resistance in patients infected with Human Immunodeficiency Virus on stable Highly Active Antiretroviral Therapy including a Protease Inhibitor after the period of 48 weeks.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2007

Completed
Last Updated

June 7, 2007

Status Verified

June 1, 2007

First QC Date

June 5, 2007

Last Update Submit

June 5, 2007

Conditions

Insulin Resistance

Keywords

insulinrosiglitazonemetforminhivprotease inhibitors

Outcome Measures

Primary Outcomes (1)

  • fasting plasma glucose, basal insulin levels

    48 weeks

Secondary Outcomes (1)

  • insulin resistance, beta cell function

    48 week

Interventions

metformin, rosiglitazoneDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Age GroupsAdult (18-64)

You may qualify if:

  • documented HIV infection
  • stable Protease Inhibitor containing HAART regimen for at least 12 months
  • impaired glucose tolerance
  • elevated insulin levels (above 20 mIU/l)

You may not qualify if:

  • patients already taking oral hypoglycaemic treatment or insulin
  • heart failure NYHA I-IV
  • liver disease or kidney disease
  • elevated AST or ALT above 2 times upper normal range
  • elevated creatinine (above 150 mmol/l)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Diabetes and Metabolic diseases

Ljubljana, Ljubljana, 1525, Slovenia

Location

Related Publications (1)

  • Silic A, Janez A, Tomazic J, Karner P, Vidmar L, Sharma P, Maticic M. Effect of rosiglitazone and metformin on insulin resistance in patients infected with human immunodeficiency virus receiving highly active antiretroviral therapy containing protease inhibitor: randomized prospective controlled clinical trial. Croat Med J. 2007 Dec;48(6):791-9. doi: 10.3325/cmj.2007.6.791.

    PMID: 18074413DERIVED

MeSH Terms

Conditions

Insulin ResistanceAcquired Immunodeficiency Syndrome

Interventions

rosiglitazone-metformin combination

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Andrej Janez, MD, PhD

    Department of Endocrinology, Diabetes and Metabolic Diseases, Medical Center Ljubljana, Zaloska 7, 1525 Ljubljana, Slovenia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2007

First Posted

June 7, 2007

Last Updated

June 7, 2007

Record last verified: 2007-06

Locations

SL(1)