Metabolic Abnormalities in HIV Infected and Uninfected Young Women

Patients on highly active antiretroviral therapy (HAART) regimens develop potentially
deleterious metabolic effects, including insulin resistance, dyslipidemia, osteopenia and
osteoporosis, and hyperlactatemia. Changes in body fat distribution and bone metabolism are
also documented. There is considerable evidence that protease inhibitors (PI) can induce
insulin resistance and increase triglyceride and cholesterol levels. It is now also clear
that both metabolic changes and fat distribution abnormalities occur in PI-naive patients
treated with nucleoside analogue reverse transcriptase inhibitors (NRTIs). In addition to
class specific effects, there is emerging evidence that there are differences within each
class of drug in the nature and magnitude of metabolic effects. This study will examine the
metabolic effects of HAART in young women.

Adolescent women aged 12 through 24 years will be recruited into each of 5 treatment strata:
Stratum 1 - HIV uninfected; Stratum 2 - HIV infected but never had HAART; Stratum 3 - HIV
infected on NNRTI regimen for 3 or more months and less than 2 weeks of PI therapy; Stratum
4 - HIV infected on PI regimen for 3 or more months and less than 2 weeks of NNRTI therapy;
and Stratum 5 - HIV infected on NRTI-only regimen for 3 or more months and less than 2 weeks
of PI or NNRTI therapy. Participants in the study will have one study visit conducted over 1
or 2 days. The study visit will include survey questionnaires, DEXA scanning, anthropometric
measurements, and blood tests examining lactate, glucose, and lipid metabolism.

Inclusion criteria

- Negative serum or urine pregnancy test if not sterilized

- Tanner Stage 4 or 5

- Accessible medical and medication history

- Willing to fast and complete clinical and laboratory evaluations

- Willingness and ability to give consent or assent with parental permission

Exclusion criteria

- Refusal to fast for 8 hours prior to specimen collection

- Unable to obtain history

- Pregnancy in last 12 months or currently pregnant

- History of anorexia or bulimia

- Type I Diabetes mellitus

- Type II Diabetes mellitus and cannot omit medication for the 48 hour period prior to
laboratory specimen collection