Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients With Insulin and Fat Abnormalities
A Randomized, Double-Blind, Placebo-Controlled Study of Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Subjects With Hyperinsulinemia and Elevated Waist/Hip Ratio
4 other identifiers
interventional
105
1 country
34
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 body's 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedJuly 22, 2013
July 1, 2013
May 1, 2001
July 19, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a viral load (level of HIV in the blood) below 10,000 copies/ml, within 30 days before study entry.
- Have a fasting blood insulin level at 15 micro IU/ml or greater; or a 2-hour insulin at least 75 micro IU/ml or greater following 75 g glucose load; or a 2-hour glucose greater than 140 mg/dl following 75 g glucose load AND fasting serum insulin at least 10 micro IU/ml or greater, within 30 days before study entry.
- Meet physical restrictions based on the amount and location of body fat and also on height and weight.
- Have noticed changes in the location of their body fat during the course of their HIV disease.
- Are 18 to 65 years old.
- Have taken the same anti-HIV drugs for at least 60 days before study entry and do not plan to change these drugs for the entire study.
- If taking hormones, have been on the same treatment for at least 6 months before study entry and do not plan to change for the entire study. Hormones include birth control pills, estrogen, or progestin for women and testosterone for men. If hormones were taken and then stopped, the treatment must have ended at least 6 months before the patient enters the study.
- Have a negative pregnancy test within 30 days before taking the study drugs, if female and able to have children.
- Agree to avoid trying to become pregnant or causing someone to become pregnant. Agree not to donate sperm or participate in other fertilization procedures. If sexually active, agree to use \[AS PER AMENDMENT 02/05/02: 1\] effective method of birth control while taking the study medications and for at least 30 days after stopping the study medications. Women who are not able to give birth or whose male partner is sterile are not required to use birth control.
- Several changes have been made to this study. In earlier versions, a fasting blood insulin above 15 micro IU/ml was the only level accepted. Now there are several other insulin/glucose levels included. In addition, the timing of pregnancy tests has changed from 14 days to 30 days.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Are allergic to metformin or rosiglitazone.
- Are pregnant or breast-feeding.
- Abuse drugs or alcohol.
- Have diarrhea, nausea, or vomiting.
- Have heart disease.
- Are taking or have taken drugs to control blood sugar.
- Have taken any of the following drugs within 6 months before study entry: high-dose estrogen, high-dose testosterone, high-dose testosterone gel, testosterone creams, growth hormone, steroids to increase body size, DHEA or androstenedione (sold over the counter), prednisone and other steroid drugs at high doses, drugs to increase appetite, experimental drugs to increase appetite or weight gain, drugs that affect the immune system, pentoxifylline, thalidomide, niacin (a multivitamin containing niacin is okay), hydroxyurea, and cimetidine.
- Are taking ritonavir with simvastatin or lovastatin (drugs to lower cholesterol).
- Are taking drugs not approved by the FDA or of unknown identity, in experimental studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Willow Clinic
Menlo Park, California, 94025, United States
Univ of California, San Diego
San Diego, California, 92103, United States
Univ of California San Francisco
San Francisco, California, 94110, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Wishard Hosp
Indianapolis, Indiana, 46202, United States
Univ of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Boston Med Ctr
Boston, Massachusetts, 02118, United States
Brigham and Women's Hosp
Boston, Massachusetts, 02215, United States
Washington Univ / St Louis Connect Care
St Louis, Missouri, 63108, United States
Washington Univ School of Medicine
St Louis, Missouri, 63108, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
Univ of Washington
Seattle, Washington, 98104, United States
Related Publications (1)
Hadigan C, Rabe J, Grinspoon S. Sustained benefits of metformin therapy on markers of cardiovascular risk in human immunodeficiency virus-infected patients with fat redistribution and insulin resistance. J Clin Endocrinol Metab. 2002 Oct;87(10):4611-5. doi: 10.1210/jc.2002-020709.
PMID: 12364443BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kathleen Mulligan
- STUDY CHAIR
Steven Grinspoon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2001
First Posted
August 31, 2001
Primary Completion
January 1, 2006
Last Updated
July 22, 2013
Record last verified: 2013-07