Metabolic Abnormalities - HIV Infected and Uninfected Males

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HIV-negative

HIV-infected and -uninfected males, ages 12 to 24 years, of Tanner Stage 4 or 5

No interventions assigned to this group

HIV-positive, has never been on ART

No interventions assigned to this group

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.

* 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.
* 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)

Minimum Eligible Age

12 Years

Maximum Eligible Age

24 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes