HIV InfectionsNCT00260936
Metabolic Abnormalities - HIV Infected and Uninfected Males
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 13 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 12 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 250 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Mar 2006to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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)
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Children's Hopsital of Boston
Boston, Massachusetts, 02115
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Children's Diagnoistic and Treatment Center
Fort Lauderdale, Florida, 33301
Childrens Hospital of Los Angeles
Los Angeles, California, 90054
University of Miami
Miami, Florida, 33101
Mount Siani Medical Center
New York, New York, 10128
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 02115
University of California at San Diego
San Diego, California, 92093
University of California at San Francisco
San Francisco, California, 94143
University of South Florida
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Childrens Hopital National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Prevalence of Morphologic and Metabolic Anormalities in HIV Infected and Uninfected Young Men
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.
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, Adolescent Males, HIV positive, Treatment Naive, Treatment Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startMar 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace Aldrovandi, MD, Study chair, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260936
- Sponsor's protocol ID
- ATN 021b
- Status last verified
- Feb 2016
- First submitted
- 30 Nov 2005
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Morphologic and Metabolic Anormalities in HIV Infected and Uninfected Young Men
- ClinicalTrials.gov ID
- NCT00260936
- Acronym / sponsor ID
- ATN 021b
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, Adolescent Males, HIV positive, Treatment Naive, Treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 2 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Website for the Adolescent Trials Network for HIV/AIDS InterventionsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Aldrovandi, MD study chair
Children's Hospital Los Angeles
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University of North Carolina, Chapel Hill at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.