CClinicalTrials.gg
CompletedNCT00260936Updated Mar 1, 2017

Metabolic Abnormalities - HIV Infected and Uninfected Males

An observational study in HIV Infections, sponsored by University of North Carolina, Chapel Hill. Completed at 13 sites in 2 countries. Open to male participants aged 12 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-01.

Sponsored by University of North Carolina, Chapel Hill · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
250
Ages
12 Years to 24 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections

Browse trials for

Keywords

  • HIV
  • AIDS
  • Adolescent Males
  • HIV positive
  • Treatment Naive
  • Treatment Experienced
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 250 is above the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 24 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

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

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)
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
250 participants (actual)

Groups and cohorts

  • 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, 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.

06

Study locations

13 sites
  • Childrens Hospital of Los Angeles
    Los Angeles, California 90054, United States
  • University of California at San Diego
    San Diego, California 92093, United States
  • University of California at San Francisco
    San Francisco, California 94143, United States
  • Childrens Hopital National Medical Center
    Washington, District of Columbia 20010, United States
  • Children's Diagnoistic and Treatment Center
    Fort Lauderdale, Florida 33301, United States
  • University of Miami
    Miami, Florida 33101, United States
  • University of South Florida
    Tampa, Florida 33606, United States
  • Stroger Hospital of Cook County
    Chicago, Illinois 60612, United States
  • Children's Hopsital of Boston
    Boston, Massachusetts 02115, United States
  • Montefiore Medical Center
    Bronx, New York 10467, United States
  • Mount Siani Medical Center
    New York, New York 10128, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 02115, United States
  • University Pediatric Hospital
    San Juan, 00936, Puerto Rico
07

References and documents

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00260936
Lead sponsor
University of North Carolina, Chapel Hill
Responsible party
Sponsor
First posted
Dec 2, 2005
Start date
Mar 2006
Primary completion
Aug 2007
Completion
Aug 2007
Last update
Mar 1, 2017

Study contacts

Grace Aldrovandi, MD
study chair · Children's Hospital Los Angeles

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion