Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients

University Medical Centre Ljubljana

Status: Completed

Conditions: Insulin Resistance

Treatments: Drug: metformin, rosiglitazone

Study type: Interventional

Funder types: Other

Identifiers

NCT00483392

J3-3545

Slovenia grant J3-3545

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)