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
- CD4 count > 200 cells/mm
- HIV RNA (viral load) <= 100,000 copies/ml
- No previous antiviral therapy
- 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
- Anemia, an Hct < 35% for men, or < 32% for women.
- Abnormal thyroid function tests.