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Metabolic Abnormalities - HIV Infected and Uninfected Males

27. Februar 2017 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

HIV-Infektionen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

250

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre bis 24 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Studienberechtigte Geschlechter

Männlich

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Anzahl der Gruppen / Kohorten

Kohorten und Interventionen

Gruppe / Kohorte
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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of North Carolina, Chapel Hill

Ermittler

Studienstuhl: Grace Aldrovandi, MD, Children's Hospital Los Angeles

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Website for the Adolescent Trials Network for HIV/AIDS Interventions

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2006

Primärer Abschluss (Tatsächlich)

1. August 2007

Studienabschluss (Tatsächlich)