Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Insulin Resistance |
| Intervention | Drug: metformin, rosiglitazone |
| Phase | N/A |
| Sponsor | University Medical Centre Ljubljana |
| Responsible Party | University Medical Centre Ljubljana |
| ClinicalTrials.gov Identifier | NCT00483392 |
| First Received | June 5, 2007 |
| Last Updated | June 5, 2007 |
| Last verified | June 2007 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 5, 2007 |
|---|---|
| Last Updated Date | June 5, 2007 |
| Start Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | fasting plasma glucose, basal insulin levels [Time Frame: 48 weeks] |
| Current Secondary Outcome Measures | insulin resistance, beta cell function [Time Frame: 48 week] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients |
|---|---|
| Official Title | Not Provided |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Insulin Resistance |
| Intervention | Drug: metformin, rosiglitazone |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | 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) |
| Gender | Male |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Not Provided |
| Contacts | Not Provided |
| Location Countries | Slovenia |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00483392 |
|---|---|
| Other Study ID Numbers | J3-3545 |
| Has Data Monitoring Committee | No |
| Information Provided By | University Medical Centre Ljubljana |
| Study Sponsor | University Medical Centre Ljubljana |
| Collaborators | Not Provided |
| Investigators | Study Chair: Andrej Janez, MD, PhD Department of Endocrinology, Diabetes and Metabolic Diseases, Medical Center Ljubljana, Zaloska 7, 1525 Ljubljana, Slovenia |
| Verification Date | June 2007 |
Locations[ + expand ][ + ]
| Department of Endocrinology, Diabetes and Metabolic diseases | Ljubljana, Slovenia, 1525 |
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