Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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metformin, rosiglitazone

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Andrej Janez, MD, PhD

Role: STUDY_CHAIR

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

Locations

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Department of Endocrinology, Diabetes and Metabolic diseases

Ljubljana, Ljubljana, Slovenia

Site Status

Countries

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Slovenia

References

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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.

Reference Type DERIVED

PMID: 18074413 (View on PubMed)

Other Identifiers

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Slovenia grant J3-3545

Identifier Type: -

Identifier Source: secondary_id

J3-3545