Status:
COMPLETED
Metabolic Abnormalities - HIV Infected and Uninfected Males
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
HIV Infections
Eligibility:
MALE
12-24 years
Brief Summary
To assess whether there exist significant differences in glucose metabolism, lipids, lactate, body composition, and bone density between HIV-infected and uninfected young men.
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 und...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00260936
Start Date
March 1 2006
End Date
August 1 2007
Last Update
March 1 2017
Active Locations (13)
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1
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90054
2
University of California at San Diego
San Diego, California, United States, 92093
3
University of California at San Francisco
San Francisco, California, United States, 94143
4
Childrens Hopital National Medical Center
Washington D.C., District of Columbia, United States, 20010