HIV Infections
Conditions
Keywords
HIV, AIDS, Adolescent Males, HIV positive, Treatment Naive, Treatment Experienced
Brief summary
To assess whether there exist significant differences in glucose metabolism, lipids, lactate, body composition, and bone density between HIV-infected and uninfected young men.
Detailed description
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.
Interventions
None listed
Sponsors
University of North Carolina, Chapel Hill
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
12 Years to 24 Years
Healthy volunteers
Yes
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)
Countries
Puerto Rico, United States
Outcome results
None listed