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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00006190 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Lipodystrophy |
Drug: Nelfinavir mesylate Drug: Stavudine Drug: Lamivudine Drug: Efavirenz |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Double-Blind, Placebo Control |
| Official Title: | The Study of Mechanisms of Lipodystrophy in HIV-Infected Patients |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390-9103 | |
| Principal Investigator: | Dr. Abhimanyu Garg | UT Southwestern Medical Center |
| Investigator: | Dr. Dolores Peterson | UT Southwestern Medical Center |
| Investigator: | Dr. Ruth Berggren | UT Southwestern Medical Center |
More Information
| Study ID Numbers: | lipod, RO1DK56583-01 |
| Study First Received: | August 25, 2000 |
| Last Updated: | August 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00006190 History of Changes |
| Health Authority: | United States: Federal Government |
|
Lipoproteins Insulin resistance Adipose tissue |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lipodystrophy Nelfinavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
Efavirenz HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Metabolic Diseases Immune System Diseases Skin Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections |