Metabolic Abnormalities - HIV Infected and Uninfected Males

The study involves a one-time collection of health and medical history data, blood and urine
specimens, and physical assessments. This study will elucidate the need for a further
in-depth study to understand the pathophysiological effects of protease inhibitor (PI)-based
and non-nucleoside analogue reverse transcriptase inhibitor (NNRTI)-based therapies in young
men.

Inclusion Criteria:

- Males age 12 years and 0 days through 24 years and 364 days.

- Tanner stage 4 or 5.

- Accessible medical history and medications history.

- Willingness to fast and complete all clinical evaluations and specimen collection.

- Willingness and ability to give informed consent or assent with parental/legal
guardian permission, where required.

Group 1: HIV-Negative Control Subject Specific Inclusion Criteria

- All subjects for Group 1 will be tested for HIV-1 to confirm negativity unless they
have a documented negative antibody test within the last three months of study entry.

- Willingness and ability to give informed consent for HIV testing. Groups 2, 3, and 4:
HIV-Positive Subject Specific Inclusion Criteria

- HIV-1 infection as documented by a positive result on any of the following licensed
tests at any time: any antibody test confirmed by Western blot, HIV culture, plasma
HIV-1 RNA PCR >1,000 copies/ml or HIV-1 DNA PCR.

- Horizontal HIV infection transmission (non-perinatal, non-transfusion acquired
infection).

- Group 2: Currently not on ART and must never have received ART.

- Group 3: Currently on a NNRTI, non-PI containing regimen for three or more months,
must never have received a total of more than six months of PI-containing regimen and
at least one year must have passed since receipt of last PI-containing regimen.

- Group 4: Currently on a PI, non-NNRTI containing regimen for three or more months,
must never have received a total of more than six months of NNRTI-containing regimen
and at least one year must have passed since receipt of last NNRTI-containing
regimen.

Exclusion Criteria:

- Transgender male to female (MTF) or female to male (FTM) youth

- Refusal to fast for the 8 hours before collection of laboratory specimen requiring
fasting.

- Unable to obtain medical/medications history.

- History of anorexia or bulimia.

- Type I Diabetes Mellitus.

- Type II Diabetes Mellitus and cannot omit diabetes medication for the 48-hour period
prior to laboratory specimen collection for oral glucose tolerance test (OGTT).

- Current use or use within the past 6 months of oxandrolone, nandrolone, oxymetholone,
stanozolol, or any other synthetic anabolic/androgenic agents.

- Current use or use within the past 6 months of pharmacologic doses of growth hormone.
Physiologic growth hormone replacement therapy is permitted, as long as dosages meet
the following specifications:

- Adolescents in puberty - less than or equal to an equivalent of 0.1 mg/kg/day

- Adolescents past puberty - less than or equal to an equivalent of 0.025 mg/kg/day

- Current use or use within the past 6 months of pharmacologic doses of testosterone.
Physiologic testosterone replacement therapy is permitted as long as dosages meet the
following specifications:

- Injection - no more than 400 mg/month of testosterone enanthate

- Patch - no more than 5 mg/day (e.g. Testoderm, Androderm)

- Gel in pre-packaged doses - no more than 7.5 g/day of gel (e.g. Androgel, Testim)