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Metabolic Abnormalities - Males
This study has been completed.
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00260936
  Purpose

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


Condition Intervention
HIV Infections
Procedure: blood draw
Procedure: urine collection

MedlinePlus related topics: AIDS
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Retrospective/Prospective Study
Official Title: Prevalence of Morphologic and Metabolic Anormalities in HIV Infected and Uninfected Young Men

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 250
Study Start Date: March 2006
Study Completion Date: August 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 24 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260936

Locations
United States, California
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90054
University of California at San Francisco
San Francisco, California, United States, 94143
University of California at San Diego
San Diego, California, United States, 92093
United States, District of Columbia
Childrens Hopital National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of South Florida
Tampa, Florida, United States, 33606
University of Miami
Miami, Florida, United States, 33101
Children's Diagnoistic and Treatment Center
Fort Lauderdale, Florida, United States, 33301
United States, Illinois
Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Massachusetts
Children's Hopsital of Boston
Boston, Massachusetts, United States, 02115
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Mount Siani Medical Center
New York, New York, United States, 10128
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 02115
Puerto Rico
University Pediatric Hospital
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Investigators
Study Chair: Grace Aldrovandi, MD Children's Hospital Los Angeles
  More Information

Website for the Adolescent Trials Network for HIV/AIDS Interventions  This link exits the ClinicalTrials.gov site

Study ID Numbers: ATN 021b
Study First Received: November 30, 2005
Last Updated: September 28, 2007
ClinicalTrials.gov Identifier: NCT00260936  
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
HIV
AIDS
Adolescent Males
HIV positive
Treatment Naive
Treatment Experienced

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Congenital Abnormalities
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009