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HIV InfectionsNCT00069004

A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth

An observational study of HIV Infections and HIV-Associated Lipodystrophy Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 38 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the prevalence of metabolic and physical abnormalities in HIV infected (via mother-to-child transmission) and uninfected children and youth. Read more about this study

Who is it for?
Ages 7 to 25 yearsHealthy volunteers can take part
How many people
450 participants
Where
38 sitesin 2 countries
Study dates
Oct 2003to Aug 2005
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 7 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • For HIV uninfected participants (Group 1)
  • HIV-1 negative (perinatally HIV-exposed but uninfected participants are eligible)
  • For HIV infected participants (Groups 2 and 3)
  • Mother-to-child (vertically) transmitted HIV infection
  • Confirmed diagnosis of HIV-1 infection by two positive assays from two different samples
  • For Group 2, cannot have taken a PI-containing regimen in the 12 months prior to study entry or have ever received a PI for 2 or more weeks
Show all 11Show fewer
  • For Group 3, must currently be taking the same PI-containing regimen taken continuously for at least 12 months prior to study entry
  • For all participants
  • Accessible medical and medications history
  • Parent, legal guardian, or participant willing to give informed consent and willing to comply with study requirements
  • Females who have begun menstruating must have negative pregnancy test

Who cannot join

  • Receipt of certain medications, including growth hormone, megestrol acetate, anabolic agents, anticytokine agents, systemic ketoconazole, systemic glucocorticoids (except if receiving stable physiologic doses), or drugs to treat osteoporosis
  • Type II diabetes mellitus and unable to omit medication prior to specimen collection
  • Pregnancy within the last 12 months, currently pregnant, or breastfeeding
  • History of eating disorder

Trial locations and contacts

38 sites in 2 countries.

38 sites in 2 countries

United States36 sites

  • Usc La Nichd Crs

    Alhambra, California, 91803

  • Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases

    Augusta, Georgia, 30912

  • Univ. of Colorado Denver NICHD CRS

    Aurora, Colorado, 80045

  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

    Baltimore, Maryland, 21287

  • UAB, Dept. of Ped., Div. of Infectious Diseases

    Birmingham, Alabama, 35233

  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases

    Boston, Massachusetts, 02115

  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS

    Brooklyn, New York, 11203

  • UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases

    Chapel Hill, North Carolina, 27599-7220

  • Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program

    Chicago, Illinois, 60608

  • Chicago Children's CRS

    Chicago, Illinois, 60614

  • DUMC Ped. CRS

    Durham, North Carolina, 27710

  • South Florida CDTC Ft Lauderdale NICHD CRS

    Fort Lauderdale, Florida, 33316

  • Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy

    Gainesville, Florida, 32610-0296

  • Texas Children's Hosp. CRS

    Houston, Texas, 77030

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.

    Long Beach, California, 90806

  • St. Jude/UTHSC CRS

    Memphis, Tennessee, 38105

  • UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases

    New Brunswick, New Jersey, 08901-1969

  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

    New Haven, Connecticut, 06510

  • Tulane/LSU Maternal/Child CRS

    New Orleans, Louisiana, 70112

  • Nyu Ny Nichd Crs

    New York, New York, 10016

  • Metropolitan Hosp. Ctr.

    New York, New York, 10029

  • Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases

    New York, New York, 10029

  • Harlem Hosp. Ctr. NY NICHD CRS

    New York, New York, 10037

  • Rutgers - New Jersey Medical School CRS

    Newark, New Jersey, 07103

  • Strong Memorial Hospital Rochester NY NICHD CRS

    Rochester, New York, 14642

  • UCSD Mother-Child-Adolescent Program CRS

    San Diego, California, 92103

  • UCSF Pediatric AIDS CRS

    San Francisco, California, 94110

  • SUNY Stony Brook NICHD CRS

    Stony Brook, New York, 11794-8111

  • SUNY Upstate Med. Univ., Dept. of Peds.

    Syracuse, New York, 13210

  • USF - Tampa NICHD CRS

    Tampa, Florida, 33606

  • Lincoln Med. & Mental Health Ctr.

    The Bronx, New York, 10451

  • Bronx-Lebanon Hosp. IMPAACT CRS

    The Bronx, New York, 10457

  • Jacobi Med. Ctr.

    The Bronx, New York, 10461

  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

    Torrance, California, 90509

  • Children's National Med. Ctr., ACTU

    Washington D.C., District of Columbia, 20010

  • Howard Univ. Washington DC NICHD CRS

    Washington D.C., District of Columbia, 20060

Other trials in United States

Puerto Rico2 sites

  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

    San Juan, 00935

  • San Juan City Hosp. PR NICHD CRS

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: Prevalence of Morphologic and Metabolic Abnormalities in Vertically HIV-Infected and Uninfected Children and Youth

The purpose of this study is to assess the prevalence of metabolic and physical abnormalities in HIV infected (via mother-to-child transmission) and uninfected children and youth. Metabolism, body composition, bone density, and other factors will be assessed in relationship to participants' exposure to highly active antiretroviral therapy (HAART).

Read the detailed description

Despite advances in HIV care associated with HAART, many patients on HAART regimens develop physical and metabolic problems, including changes in body fat distribution (lipodystrophy), osteopenia and osteoporosis, dyslipidemia, and hyperlactatemia. Early studies suggest that protease inhibitors (PIs) were directly responsible for HIV Lipodystrophy Syndrome (HLS) and skeletal complications in HAART-treated patients. This study will compare HIV infected, HAART-treated children and youth and their uninfected counterparts to make connections between HAART, HLS, and skeletal and metabolic problems. The study is the first to address the prevalence and risk assessment of these complications in children, and will be useful in predicting long-term prognosis in HIV patients who use or have used HAART.

There will be three groups in the study. Group 1 participants will be uninfected volunteers who will receive no protocol-specific treatment or other intervention. Vertically infected HIV patients in Groups 2 and 3 will continue their current HAART either on a non-PI-containing regimen (Group 2) or a PI-containing regimen (Group 3). Screening evaluations will be conducted within 30 days prior to study entry. Study evaluations may be completed at study entry or over the course of up to 3 study visits. All participants will undergo whole body and regional DEXA scans (to assess bone density), measurements to determine sexual maturity, and blood work.

Keywords
HIV-Associated Lipodystrophy Syndrome, HIV Lipodystrophy Syndrome, Treatment Experienced, Lipodystrophy, Dyslipidemia, Osteoporosis, Osteopenia
Medical subject headings
HIV Infections, HIV-Associated Lipodystrophy Syndrome, Lipodystrophy, Dyslipidemias, Osteoporosis, Bone Diseases, Metabolic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2003 (estimated)
  2. Study startOct 2003
  3. Study completionAug 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
450 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00069004
Sponsor's protocol ID
P1045
Other IDs
10108, PACTG P1045
Status last verified
Jan 2014
First submitted
12 Sep 2003
Last updated
7 Jan 2014
Results posted
No

Publications

  • Wanke CA, Falutz JM, Shevitz A, Phair JP, Kotler DP. Clinical evaluation and management of metabolic and morphologic abnormalities associated with human immunodeficiency virus. Clin Infect Dis. 2002 Jan 15;34(2):248-59. doi: 10.1086/324744. Epub 2001 Dec 7.

    PubMed 11740715

  • Smith KY. Selected metabolic and morphologic complications associated with highly active antiretroviral therapy. J Infect Dis. 2002 May 15;185 Suppl 2:S123-7. doi: 10.1086/340200.

    PubMed 12001033

  • Currier J, Carpenter C, Daar E, Kotler D, Wanke C. Identifying and managing morphologic complications of HIV and HAART. AIDS Read. 2002 Mar;12(3):114-9, 124-5.

    PubMed 11966241

  • Carr A, Samaras K, Thorisdottir A, Kaufmann GR, Chisholm DJ, Cooper DA. Diagnosis, prediction, and natural course of HIV-1 protease-inhibitor-associated lipodystrophy, hyperlipidaemia, and diabetes mellitus: a cohort study. Lancet. 1999 Jun 19;353(9170):2093-9. doi: 10.1016/S0140-6736(98)08468-2.

    PubMed 10382692

  • Bockhorst JL, Ksseiry I, Toye M, Chipkin SR, Stechenberg BW, Fisher DJ, Allen HF. Evidence of human immunodeficiency virus-associated lipodystrophy syndrome in children treated with protease inhibitors. Pediatr Infect Dis J. 2003 May;22(5):463-5.

    PubMed 12797313

  • Tebas P, Powderly WG, Claxton S, Marin D, Tantisiriwat W, Teitelbaum SL, Yarasheski KE. Accelerated bone mineral loss in HIV-infected patients receiving potent antiretroviral therapy. AIDS. 2000 Mar 10;14(4):F63-7. doi: 10.1097/00002030-200003100-00005.

    PubMed 10770534

  • Jacobson DL, Lindsey JC, Gordon CM, Moye J, Hardin DS, Mulligan K, Aldrovandi GM; Pediatric AIDS Clinical Trials Group P1045 team. Total body and spinal bone mineral density across Tanner stage in perinatally HIV-infected and uninfected children and youth in PACTG 1045. AIDS. 2010 Mar 13;24(5):687-96. doi: 10.1097/QAD.0b013e328336095d.

    PubMed 20168204

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections and HIV-Associated Lipodystrophy Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 38 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 11 inclusion and 4 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 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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?

On the ClinicalTrials.gov record for NCT00069004, which also lists 7 linked publications.

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 7 Jan 2014.

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