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Metabolic Abnormalities - HIV Infected and Uninfected Males

27 febbraio 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Infezioni da HIV

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

250

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 24 anni (Bambino, Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Maschio

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte Gruppo / Coorte Un gruppo o sottogruppo di partecipanti a uno studio osservazionale che viene valutato per gli esiti biomedici o sanitari.
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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of North Carolina, Chapel Hill

Investigatori

Cattedra di studio: Grace Aldrovandi, MD, Children's Hospital Los Angeles

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Website for the Adolescent Trials Network for HIV/AIDS Interventions

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2006

Completamento primario (Effettivo)

1 agosto 2007

Completamento dello studio (Effettivo)

1 agosto 2007

Date di iscrizione allo studio

Primo inviato

30 novembre 2005

Primo inviato che soddisfa i criteri di controllo qualità