Mechanisms of Lipodystrophy in HIV-Infected Pateints
University of Texas Southwestern Medical Center
Information provided by (Responsible Party)
University of Texas Southwestern Medical Center
First received: April 4, 2007
Last updated: May 29, 2015
Last Verified: August 2014
History of Changes
The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not
known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and
reduction in viral load contribute to the development of lipodystrophy syndrome is not clear.
The project therefore has the following aims: 1) to characterize metabolic abnormalities and changes in body fat distribution, 2) to develop objective criteria for defining the syndrome and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the lipodystrophy syndrome in HIV-infected patients.
Drug : Viracept versus Sustiva with stavudine and epivir
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Mecahnisms of Lipodystrophy in HIV-Infected Patients|
Further study details as provided by University of Texas Southwestern Medical Center:
Primary Outcome Measures
- Effect of drug regimens on adiposity overall and regional at year one and year two as compared to baseline
- Effect of drug regimens on plasma glucose and insulin during OGTT at year one and two as compared with baseline
- Effect of drug regimens on serum triglycerides and HDL cholesterol at year one and two as compared with baseline
- Multiple regression models will also be constructed to assess which factors in addition to PI therapy explain the variability in body fat changes, serum glucose, insulin and lipoproteins.
|Study Start Date:||February 2002|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
A 2-year long prospective, randomized, double blind, placebo-controlled study in 200 asymptomatic HIV (+) patients to compare two equally effective antiretroviral regimens, one with and the other without a protease inhibiotor. We will study body fat distribution by anthropometry and magnetic resonance imaging and will measure insulin sensitivity (in a subset of patients), plasma lipoproteins, glucose tolerance and other metabolic variables. We will study expression of an array of adipocyte specific proteins/transcription factors involved in adipocyte differentiation, insulin action and lipoprotein metabolism in fat biopsy samples obtained before and after institution of therapy.Eligibility
|Ages Eligible for Study:||18 Years to 70 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- HIV Positive
- No previous antiviral therapy
- 18 to 70 years of age
- Patients with opportunistic infections or AIDS.
- Active intravenous drug users.
- Patients on corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications, dehydroepiandrosterone, oxandrolone, megace.
- Patients with diabetes mellitus.
- Patients with moderate to heavy alcohol consumption ( greater than 15 drinks per week).
- Pregnant or premenopausal women, unless surgically sterilized or highly unlikely to conceive (defined as women taking oral contraceptives, using barrier protection during intercourse or with a copper intrauterine device in place for > 3 months without complaints and a negative serum or urine pregnancy test within 30 days of study entry).
- Acute or chronic liver diseases; elevations of liver transaminases by more than two and one half times above the upper limits of normal ( SGOT > 105 U/L, SGPT > 120 U/L, ) or a total bilirubin of > 1.5mg/dL.
- Anemia (hematocrit <32%).
- Abnormal thyroid function tests.
- Weight loss >10% from baseline in the past year.
- Recent (within the past year), history of suicide attempt.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457665
Locations Show More
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
Sponsors and CollaboratorsUniversity of Texas Southwestern Medical Center
|Principal Investigator:||Abhimanyu Garg, M.D.||University of Texas Southwestern Medical Center Dallas|
|Responsible Party:||University of Texas Southwestern Medical Center|
|ClinicalTrials.gov Identifier:||NCT00457665 History of Changes|
|Other Study ID Numbers:||R01-56583|
|Study First Received:||April 4, 2007|
|Last Updated:||May 29, 2015|
Keywords provided by University of Texas Southwestern Medical Center:HIV
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.