NCT00260936

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

November 30, 2005

Last Update Submit

February 27, 2017

Conditions

HIV Infections

Keywords

HIVAIDSAdolescent MalesHIV positiveTreatment NaiveTreatment Experienced

Study Arms (4)

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.

Eligibility Criteria

Age12 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Childrens Hospital of Los Angeles

Los Angeles, California, 90054, United States

Location

University of California at San Diego

San Diego, California, 92093, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Childrens Hopital National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Children's Diagnoistic and Treatment Center

Fort Lauderdale, Florida, 33301, United States

Location

University of Miami

Miami, Florida, 33101, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Children's Hopsital of Boston

Boston, Massachusetts, 02115, United States

Location

Mount Siani Medical Center

New York, New York, 10128, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 02115, United States

Location

University Pediatric Hospital

San Juan, 00936, Puerto Rico

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeHIV Seropositivity

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Grace Aldrovandi, MD

    Children's Hospital Los Angeles

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 2, 2005

Study Start

March 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

March 1, 2017

Record last verified: 2016-02

Locations

US(12)PR(1)