Metabolic Abnormalities - HIV Infected and Uninfected Males

Completed

Conditions studied: HIV Infections

In brief

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

Key facts

Study ID: NCT00260936
Run by: University of North Carolina, Chapel Hill
People needed: 250
Starts: 2006-03-01
Expected to finish: 2007-08-01
Last updated by the study team: 2017-03-01

Who can join

Age: 12 and older, up to 24. Sex: male. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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)

Where it is running

Childrens Hospital of Los Angeles — Los Angeles, California, United States
University of California at San Diego — San Diego, California, United States
University of California at San Francisco — San Francisco, California, United States
Childrens Hopital National Medical Center — Washington D.C., District of Columbia, United States
Children's Diagnoistic and Treatment Center — Fort Lauderdale, Florida, United States
University of Miami — Miami, Florida, United States
University of South Florida — Tampa, Florida, United States
Stroger Hospital of Cook County — Chicago, Illinois, United States
Children's Hopsital of Boston — Boston, Massachusetts, United States
Mount Siani Medical Center — New York, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
University Pediatric Hospital — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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