Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients

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.

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Key information

Conditions

Insulin Resistance Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Glucose Metabolism Disorders HIV Infections Hyperinsulinism Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Diabetes and Metabolic diseases

Ljubljana, 1525, Slovenia

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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)

Treatment and study plan

metformin, rosiglitazone

Drug

Primary outcomes

fasting plasma glucose, basal insulin levels

Time frame: 48 weeks

Secondary outcomes

insulin resistance, beta cell function

Time frame: 48 week

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Important dates

First posted: Jun 7, 2007
Registry last updated: Jun 7, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed