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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-negative | HIV-infected and -uninfected males, ages 12 to 24 years, of Tanner Stage 4 or 5 | ||
| HIV-positive, has never been on ART | HIV-positive, has never been on ART | ||
| HIV-positive, non PI containing NNRTI-based regimen | 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 | 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. |
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Inclusion Criteria:
Group 1: HIV-Negative Control Subject Specific Inclusion Criteria
Exclusion Criteria:
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Approximately 250 subjects will be enrolled in the study. The number of subjects enrolled in each study group will be as follows: 50 HIV-negative subjects; 100 HIV-positive subjects who are antiretroviral therapy (ART) naïve; and two groups of up to 50 HIV-positive subjects each, one on an NNRTI-based regimen and the other on a PI-based regimen.
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| Name | Affiliation | Role |
|---|---|---|
| Grace Aldrovandi, MD | Children's Hospital Los Angeles | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Hospital of Los Angeles | Los Angeles | California | 90054 | United States | ||
| University of California at San Diego |
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| Label | URL |
|---|---|
| Website for the Adolescent Trials Network for HIV/AIDS Interventions | View source |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| San Diego |
| California |
| 92093 |
| United States |
| University of California at San Francisco | San Francisco | California | 94143 | United States |
| Childrens Hopital National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Children's Diagnoistic and Treatment Center | Fort Lauderdale | Florida | 33301 | United States |
| University of Miami | Miami | Florida | 33101 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Stroger Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Children's Hopsital of Boston | Boston | Massachusetts | 02115 | United States |
| Mount Siani Medical Center | New York | New York | 10128 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 02115 | United States |
| University Pediatric Hospital | San Juan | 00936 | Puerto Rico |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |