Metabolic Abnormalities - HIV Infected and Uninfected Males

HIV Infections Clinical Trial

Official title:

Prevalence of Morphologic and Metabolic Anormalities in HIV Infected and Uninfected Young Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00260936
• Other study ID #: ATN 021b
• Status: Completed
• Phase: N/A
• First received: November 30, 2005
• Last updated: February 27, 2017
• Start date: March 2006
• Est. completion date: August 2007

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 12 Years to 24 Years

Eligibility

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)

Related Conditions & MeSH terms

• HIV Infections

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Countries where clinical trial is conducted

United States,  Puerto Rico, 

External Links

•   Website for the Adolescent Trials Network for HIV/AIDS Interventions