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Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities Clinical research trials and Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities. Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities clinical trial. Test subjects typically receive the most expert healthcare available for their Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities  Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities
Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities
For Condition: Lipodystrophy,Hyperinsulinemia,HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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 02/05/02: Evaluations must be performed under fasting conditions.] Safety indices, fasting insulin and glucose levels, visceral [AS PER AMENDMENT 02/05/02: and subcutaneous abdominal] fat are assessed. [AS PER AMENDMENT 02/05/02: 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 02/05/02: 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.]
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. Exclusion Criteria 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.
Total Enrollment: 160
Location and Contact Information:
Overall Study Official:
KathleenMulligan, Study Chair,
Stanford Univ Med Ctr *No longer recruiting*
Stanford, California, 943055107
United States
No longer recruiting
Johns Hopkins Hosp *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Charles Raines 410-614-4487
Univ of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Joseph Quinn 215-349-8092
Boston Med Ctr *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Christine Johnsen 617-414-7831
Univ of Cincinnati *Recruiting*
Cincinnati, Ohio, 452670405
United States
Recruiting Tammy Powell 513-584-8373
Ohio State Univ Hosp Clinic *Recruiting*
Columbus, Ohio, 432101228
United States
Recruiting Judith Neidig 614-293-8112
Univ of North Carolina *No longer recruiting*
Chapel Hill, North Carolina, 275997215
United States
No longer recruiting
San Mateo AIDS Program / Stanford Univ *No longer recruiting*
Stanford, California, 943055107
United States
No longer recruiting
Univ of Nebraska Med Ctr *Recruiting*
Omaha, Nebraska, 681985130
United States
Recruiting Frances Meter 402-559-8163
Univ of Washington *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
Univ of Pittsburgh *No longer recruiting*
Pittsburgh, Pennsylvania, 15213
United States
No longer recruiting
UCLA CARE Ctr *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Susan McCarthy 310-206-8029
Georgetown Univ Med Ctr *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Candance Levy 202-687-5378
Indiana Univ Hosp *Recruiting*
Indianapolis, Indiana, 462025250
United States
Recruiting Beth Zwickl 317-274-8456
Rush Presbyterian - Saint Luke's Med Ctr *No longer recruiting*
Chicago, Illinois, 60612
United States
No longer recruiting
Bellevue Hosp / New York Univ Med Ctr *Recruiting*
New York City, New York, 10016
United States
Recruiting Maura Laverty 212-263-6565
Wishard Hosp *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Scott Hamilton 317-630-6023
Univ of Southern California / LA County USC Med Ctr *Recruiting*
Los Angeles, California, 900331079
United States
Recruiting Luis Mendez 323-343-8283
The CORE Ctr *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Joanne Despotes 312-572-4545
Univ of California, San Diego *Recruiting*
San Diego, California, 92103
United States
Recruiting Jill Kunkel 619-543-8080
Methodist Hosp of Indiana / Life Care Clinic *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Sarah Ryan 317-929-2917
Univ of Maryland, Institute of Human Virology *No longer recruiting*
Baltimore, Maryland, 21201
United States
No longer recruiting
Washington Univ / St Louis Connect Care *No longer recruiting*
St. Louis, Missouri, 63108
United States
No longer recruiting
Univ of California San Francisco *Recruiting*
San Francisco, California, 94110
United States
Recruiting Julieann Lewis 415-514-0550
Univ of Alabama at Birmingham *No longer recruiting*
Birmingham, Alabama, 35294
United States
No longer recruiting
Univ of Hawaii *Recruiting*
Honolulu, Hawaii, 96816
United States
Recruiting Debra Ogata-Arakaki 808-737-2751
Northwestern Univ Med School *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Baiba Berzins 312-695-5012
Brigham and Women's Hosp *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Carolyn Koziol 617-732-5635
Washington Univ School of Medicine *Recruiting*
St. Louis, Missouri, 63108
United States
Recruiting Michael Klebert 314-454-0058
Beth Israel Med Ctr *Recruiting*
New York City, New York, 10003
United States
Recruiting Ann Marshak 212-420-4432
Willow Clinic *No longer recruiting*
Menlo Park, California, 94025
United States
No longer recruiting
Harvard (Massachusetts Gen Hosp) *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Teri Flynn 617-726-3819
Vanderbilt Univ Med Ctr *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Victoria Harris 615-467-0154
Univ of Colorado Health Sciences Ctr *No longer recruiting*
Denver, Colorado, 80262
United States
No longer recruiting
Additional Information:
Study ID Numbers: ACTG A5082; AACTG A5082
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015691
Other Hiv Infections Studies:
1. A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex
2. A Study of d4T in Patients with AIDS or AIDS-Related Complex Who Cannot Take AZT
3. Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia
4. A Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment
5. Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
Related Studies:
Other HIV Infections Clinical Trials
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Other Chicago Clinical Trials
Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities
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