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

Learn more about:
Related Clinical Trial
Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH. Hemoglobin Level, Coagulopathy Profile and Electrolyte Balance Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome Exercise and Pioglitazone for HIV-Metabolic Syndromes Observational Study of Changes in Fat Distribution and Blood Metabolites in HIV Infected Adults Yoga for the Management of HIV-Metabolic Syndromes Pravastatin for Hyperlipidaemia in HIV. A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth Exercise for Patients With HIV Infections Lactate Metabolism Study in HIV Infected Persons Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients With Insulin and Fat Abnormalities Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients Safety Study of Antria Cell Preparation Process to Enhance Facial Fat Grafting With Adipose Derived Stem Cells Growth Hormone Dynamics and Cardiac Steatosis in HIV The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children Immune Response to Pneumococcal Vaccination in Aging HIV Positive Adults Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers Detraining in People Living With HIV/AIDS SHARE: Simple HAART With Abacavir, Reyataz, and Epivir The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS Observational Study of Fat Loss in HIV Infected Adults Taking Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Metabolism and Body Shape of Healthy Children and Children With Chronic Infections Changing to Nonprotease Inhibitor Treatment to Improve Side Effects Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients With Abnormal Blood Lipids Perceived Changes in Body Build and Image in Patients Who Are Now Taking or Recently Have Stopped Taking Anti-HIV Drugs White Light Scanning to Aid Body Contouring: A Pilot Project Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy The Cleveland Cardiometabolic Cohort Metabolic Abnormalities in HIV-infected Persons Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients. Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome Effects of Short-term Growth Hormone in HIV-infected Patients Safety Study of Filler Agent Composed of Autologous Mesenchymal Stem Cells and Hyaluronic Acid Raltegravir Therapy for Women With HIV and Fat Accumulation The PREFORM Study: A Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring Effects of IGF-I in HIV Metabolic Disease Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy Effects of Growth Hormone Releasing Hormone in HIV A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy Body Composition and Adipose Tissue in HIV Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue CONFORM: Rotational Fractional Resection for Submental Contouring Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy TH9507 in Patients With HIV-Associated Lipodystrophy TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy Energy Expenditure of People Living With HIV/AIDS Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS) Egrifta Replacement and Sleep Disordered Breathing Clinical Trial to Determine the Efficacy of Sculptra™ Dermal Filler for the Correction of Contour Deformities Caused by Lipoatrophy Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients Low Energy Diet and Familial Partial Lipodystrophy Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy Adipocyte, Insulin-resistance and Immunity : Evaluation of Interleukin-7 in Lipodystrophy, Diabetes and Obesity Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy Role of the Autonomic Nervous System in HIV-Lipodystrophy Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome Therapeutic Approaches to HAART-Induced Lipodystrophy Different Surgical Modalities for Thigh Lipodystrophy Including Liposuction,Thigh Lift and Liposuction Assisted Thigh Lift Leptin to Treat Lipodystrophy Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy Prevalence of Lipodystrophy Syndrome and Its Role as Cause of Metabolic Disturbances Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension Shock Waves for Treatment of Gynoid Lipodystrophy and Localized Fat Corticosteroid-induced Lipodystrophy and Adipokines Short-term Effects of Leptin in People With Lipodystrophy Leptin to Treat Lipodystrophy Lipodystrophy Connect Patient Registry An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy

Brief Title

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

Official Title

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

Brief 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.
      Metabolism, body composition, bone density, and other factors will be assessed in
      relationship to participants' exposure to highly active antiretroviral therapy (HAART).
    

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.
    


Study Type

Observational




Condition

HIV Infections



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

450

Start Date

October 2003

Completion Date

August 2005


Eligibility Criteria

        Inclusion Criteria

        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

          -  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

        Exclusion Criteria

          -  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
      

Gender

All

Ages

7 Years - 25 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Grace Aldrovandi, MD, , 

Location Countries

Puerto Rico

Location Countries

Puerto Rico

Administrative Informations


NCT ID

NCT00069004

Organization ID

P1045

Secondary IDs

10108

Responsible Party

Sponsor

Study Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Sponsor

Grace Aldrovandi, MD, Study Chair, University of Alabama at Birmingham


Verification Date

January 2014