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Metabolic Abnormalities - HIV Infected and Uninfected Males

27. februar 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

HIV-infeksjoner

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

250

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 24 år (Barn, Voksen)

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of North Carolina, Chapel Hill

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Website for the Adolescent Trials Network for HIV/AIDS Interventions

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2006

Primær fullføring (Faktiske)

1. august 2007

Studiet fullført (Faktiske)