- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00260936
Metabolic Abnormalities - HIV Infected and Uninfected Males
27 februari 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
250
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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Los Angeles, California, Förenta staterna, 90054
- Childrens Hospital of Los Angeles
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San Diego, California, Förenta staterna, 92093
- University of California at San Diego
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San Francisco, California, Förenta staterna, 94143
- University of California at San Francisco
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20010
- Childrens Hopital National Medical Center
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Florida
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Fort Lauderdale, Florida, Förenta staterna, 33301
- Children's Diagnoistic and Treatment Center
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Miami, Florida, Förenta staterna, 33101
- University of Miami
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Tampa, Florida, Förenta staterna, 33606
- University of South Florida
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Stroger Hospital of Cook County
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Children's Hopsital of Boston
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New York
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Bronx, New York, Förenta staterna, 10467
- Montefiore Medical Center
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New York, New York, Förenta staterna, 10128
- Mount Siani Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 02115
- Children's Hospital of Philadelphia
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-
-
-
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San Juan, Puerto Rico, 00936
- University Pediatric Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
12 år till 24 år (Barn, Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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HIV-negative
HIV-infected and -uninfected males, ages 12 to 24 years, of Tanner Stage 4 or 5
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HIV-positive, has never been on ART
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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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studiestol: Grace Aldrovandi, MD, Children's Hospital Los Angeles
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2006
Primärt slutförande (Faktisk)
1 augusti 2007
Avslutad studie (Faktisk)
1 augusti 2007
Studieregistreringsdatum
Först inskickad
30 november 2005
Först inskickad som uppfyllde QC-kriterierna
30 november 2005
Första postat (Uppskatta)
2 december 2005
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 mars 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 februari 2017
Senast verifierad
1 februari 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ATN 021b
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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