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A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy Clinical research trials and A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy. A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy clinical trial. Human subjects often get the best healthcare available for their A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy  A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy
A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy
For Condition: HIV Infections,Lipodystrophy
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: HIV infection is a major global health problem. Survival and quality of life for HIV subjects has tremendously improved with the advent of a class of antivirals called protease inhibitors and the utilization of highly active combination therapy. However, such therapy has been associated with a syndrome called lipodystrophy. This lipodystrophy syndrome causes body shape changes; typically thinning and loss of fat from the arms, legs and face, with increased fat appearing in the abdomen and neck. There are also metabolic changes which occur, and subjects can develop increased triglycerides, increased cholesterol and an increased risk for diabetes as indicated by increasing insulin resistance. This study will take HIV positive subjects who have not yet started antiviral medications (treatment naive)and randomly assign them to one of two treatment arms. These treatment arms will be: Sustiva/Zerit/Epivir vs. Viracept/Zerit/Epivir The subjects will be treated and followed for two years and have extensive metabolic testing, skinfold thickness measurements, MRI scans and other measures to determine if and how they are experiencing changes in metabolism or body shape and to discover the mechanism of why this occurs. Understanding the mechanism should allow researchers to design interventions for subjects who have lipodystrophy and strategies to prevent lipodystrophy from occurring to subjects treated with antivirals in the future.
Details:
Eligibility:
Study Type: Interventional, Diagnostic, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - CD4 count > 200 cells/mm - HIV RNA (viral load) <= 100,000 copies/ml - No previous antiviral therapy Exclusion Criteria: - AIDS or opportunistic infections - Active intravenous drug users - Use of: corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications, oxandrolone, megace, dehydroepiandrosterone. - Subjects with diabetes mellitus - Subjects who consume > 2 alcoholic drinks per day - Pregnant women, premenopausal women unless adequate birth control is in use. - Acute or chronic liver diseases, liver enzymes elevations > 2.5 times the upper limit of normal. - Anemia, an Hct < 35% for men, or < 32% for women. - Abnormal thyroid function tests.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Dr.Garg, Principal Investigator, UT Southwestern Medical Center
UT Southwestern Medical Center
Dallas, Texas, 75390-9103
United States
Additional Information:
Study ID Numbers: lipod; RO1DK56583-01
Study Start Date: November 2000
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006190
Other Lipodystrophy Studies:
1. A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
2. Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities
3. Changing to Nonprotease Inhibitor Treatment to Improve Side Effects
4. A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy
5. Leptin to Treat Lipodystrophy
Related Studies:
Other Lipodystrophy Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
A Study to determine how and why HIV-Infected subjects on anti-viral treatment develop Lipodystrophy
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