Metabolic Abnormalities - HIV Infected and Uninfected Males

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevalence of Morphologic and Metabolic Anormalities in HIV Infected and Uninfected Young Men

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-negative<br>HIV-infected and -uninfected males, ages 12 to 24 years, of Tanner Stage 4 or 5 | |
| HIV-positive, has never been on ART<br>HIV-positive, has never been on ART | |
| HIV-positive, non PI containing NNRTI-based regimen<br>HIV-positive, currently on a non-PI-containing NNRTI-based regimen for at least 12 weeks. Must never have received a total of more than 6 months of PI-containing regimen, and at least one year must have passed since receipt of last PI-containing regimen | |
| HIV-positive, non-NNRTI-containing PI-based regimen<br>HIV-positive, currently on a non-NNRTI-containing PI-based regimen for at least 12 weeks. Must never have received a total of more than 6 months of NNRTI-containing regimen, and at least one year must have passed since receipt of last NNRTI-containing regimen. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, Adolescent Males, HIV positive, Treatment Naive, Treatment Experienced