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Metabolic Abnormalities - HIV Infected and Uninfected Males

27. února 2017 aktualizováno: University of North Carolina, Chapel Hill

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

To assess whether there exist significant differences in glucose metabolism, lipids, lactate, body composition, and bone density between HIV-infected and uninfected young men.

Přehled studie

Postavení

Dokončeno

Podmínky

HIV infekce

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

250

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Portoriko
- - San Juan, Portoriko, 00936
    - University Pediatric Hospital
Spojené státy
- California
  - Los Angeles, California, Spojené státy, 90054
    - Childrens Hospital of Los Angeles
  - San Diego, California, Spojené státy, 92093
    - University of California at San Diego
  - San Francisco, California, Spojené státy, 94143
    - University of California at San Francisco
- District of Columbia
  - Washington, District of Columbia, Spojené státy, 20010
    - Childrens Hopital National Medical Center
- Florida
  - Fort Lauderdale, Florida, Spojené státy, 33301
    - Children's Diagnoistic and Treatment Center
  - Miami, Florida, Spojené státy, 33101
    - University of Miami
  - Tampa, Florida, Spojené státy, 33606
    - University of South Florida
- Illinois
  - Chicago, Illinois, Spojené státy, 60612
    - Stroger Hospital of Cook County
- Massachusetts
  - Boston, Massachusetts, Spojené státy, 02115
    - Children's Hopsital of Boston
- New York
  - Bronx, New York, Spojené státy, 10467
    - Montefiore Medical Center
  - New York, New York, Spojené státy, 10128
    - Mount Siani Medical Center
- Pennsylvania
  - Philadelphia, Pennsylvania, Spojené státy, 02115
    - Children's Hospital of Philadelphia

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

12 let až 24 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Mužský

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Počet skupin / kohort

Kohorty a intervence

Skupina / kohorta
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, 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of North Carolina, Chapel Hill

Vyšetřovatelé

Studijní židle: Grace Aldrovandi, MD, Children's Hospital Los Angeles

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Website for the Adolescent Trials Network for HIV/AIDS Interventions

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. března 2006

Primární dokončení (Aktuální)

1. srpna 2007

Dokončení studie (Aktuální)