Clinical trial NCT00260936: Metabolic Abnormalities - HIV Infected and Uninfected Males
Official title: Prevalence of Morphologic and Metabolic Anormalities in HIV Infected and Uninfected Young Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
AIDS
Adolescent Males
HIV positive
Treatment Naive
Treatment Experienced
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2005-12-02
Enrollment: 250
Sex: MALE
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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 understand the pathophysiological effects of protease inhibitor (PI)-based and non-nucleoside analogue reverse transcriptase inhibitor (NNRTI)-based therapies in young men.

Eligibility 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital of Los Angeles
state: California
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Washington
country: United States
facility: Childrens Hopital National Medical Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Children's Diagnoistic and Treatment Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: Boston
country: United States
facility: Children's Hopsital of Boston
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mount Siani Medical Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: San Juan
country: Puerto Rico
facility: University Pediatric Hospital
Study officials:
affiliation: Children's Hospital Los Angeles
name: Grace Aldrovandi, MD
role: STUDY_CHAIR
References: