A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy
Status:
Completed
Trial end date:
2001-11-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)