Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015691
Status:
COMPLETED
Last Update Posted:
2013-07-22
First Post:
2001-05-01
Brief Title:
Metformin and Rosiglitazone Alone or in Combination in HIV-Infected Patients With Insulin and Fat Abnormalities
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of Metformin and Rosiglitazone Alone or in Combination in HIV-Infected Subjects With Hyperinsulinemia and Elevated WaistHip Ratio
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see whether metformin alone rosiglitazone alone or metformin and rosiglitazone together will lower insulin levels in the blood and decrease fat in the abdomen or other parts of the body
Studies have shown that certain anti-HIV medications can cause a number of side effects including high blood sugar resulting from the bodys failure to use insulin high insulin and excess fat build-up in the abdominal area These side effects are known to increase the risk of heart disease Metformin and rosiglitazone are 2 drugs that have been shown to lower insulin resistance and lessen abdominal fat in patients who are not HIV-infected This study will investigate the use of these drugs in HIV-infected patients
Studies have shown that certain anti-HIV medications can cause a number of side effects including high blood sugar resulting from the bodys failure to use insulin high insulin and excess fat build-up in the abdominal area These side effects are known to increase the risk of heart disease Metformin and rosiglitazone are 2 drugs that have been shown to lower insulin resistance and lessen abdominal fat in patients who are not HIV-infected This study will investigate the use of these drugs in HIV-infected patients
Detailed Description:
Recent studies have documented hyperglycemia insulin resistance and glucose intolerance in a seemingly increasing proportion of patients with HIV infection Other studies have described a variety of syndromes of fat accumulation and fat loss including abdominal obesity Although initially attributed specifically to protease inhibitors PI these abnormalities also have been observed in antiretroviral-experienced but PI-naive patients Hyperinsulinemia and abdominal obesity are strong independent risk factors for coronary artery disease In noninfected patients metformin and thiazolidinediones have been shown to reduce insulin resistance by different mechanisms and also to reduce visceral adiposity This study investigates the use of metformin and rosiglitazone a member of the thiazolidinedione class in HIV-infected patients with hyperinsulinemia and central fat accumulation
At study entry clinical and laboratory assessments are performed A standard OGTT with plasma samples drawn over 120 minutes will be performed for glucose and insulin determinations After completion of entry evaluations patients are assigned randomly to 1 of 4 double-blinded treatment arms
Arm A Metformin plus rosiglitazone placebo Arm B Metformin placebo plus rosiglitazone Arm C Metformin plus rosiglitazone Arm D Metformin placebo plus rosiglitazone placebo Patients who are still on study drugs at Week 16 at either full or reduced dose are switched to the open-label phase to receive the combination of metformin and rosiglitazone through Week 32 Patients have evaluations at Weeks 2 4 8 12 16 18 20 24 28 and 32 AS PER AMENDMENT 020502 Evaluations must be performed under fasting conditions Safety indices fasting insulin and glucose levels visceral AS PER AMENDMENT 020502 and subcutaneous abdominal fat are assessed AS PER AMENDMENT 020502 Patients who discontinue study treatment due to pregnancy during the study will have the Week 32 evaluations except CT and DEXA scans AS PER AMENDMENT 020502 A mid-thigh measurement was added to the study as a secondary endpoint to look for changes in extremity subcutaneous fat from therapy with rosiglitazone Rosiglitazone and other peroxisome proliferator-activated receptor PPAR gamma activators increase subcutaneous adipogenesis and may thus increase subcutaneous fat and improve insulin resistance in this way
At study entry clinical and laboratory assessments are performed A standard OGTT with plasma samples drawn over 120 minutes will be performed for glucose and insulin determinations After completion of entry evaluations patients are assigned randomly to 1 of 4 double-blinded treatment arms
Arm A Metformin plus rosiglitazone placebo Arm B Metformin placebo plus rosiglitazone Arm C Metformin plus rosiglitazone Arm D Metformin placebo plus rosiglitazone placebo Patients who are still on study drugs at Week 16 at either full or reduced dose are switched to the open-label phase to receive the combination of metformin and rosiglitazone through Week 32 Patients have evaluations at Weeks 2 4 8 12 16 18 20 24 28 and 32 AS PER AMENDMENT 020502 Evaluations must be performed under fasting conditions Safety indices fasting insulin and glucose levels visceral AS PER AMENDMENT 020502 and subcutaneous abdominal fat are assessed AS PER AMENDMENT 020502 Patients who discontinue study treatment due to pregnancy during the study will have the Week 32 evaluations except CT and DEXA scans AS PER AMENDMENT 020502 A mid-thigh measurement was added to the study as a secondary endpoint to look for changes in extremity subcutaneous fat from therapy with rosiglitazone Rosiglitazone and other peroxisome proliferator-activated receptor PPAR gamma activators increase subcutaneous adipogenesis and may thus increase subcutaneous fat and improve insulin resistance in this way
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10913 | REGISTRY | DAIDS-ES | None |
| AACTG A5082 | None | None | None |
| ACTG A5082 | None | None | None |