The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children

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

The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children

Official Title

Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children

Brief Summary

      The purpose of this study is to see how beginning or changing anti-HIV medications affects
      the body composition (weight, height, growth, body fat, and muscle mass, or fat and muscle
      distribution) of HIV-infected children. This study also looks at how changes in body
      composition relate to changes in viral load (level of HIV in the blood), CD4 cell counts,
      height, and weight in HIV-infected children. This study also compares changes in body
      composition to levels of cytokines (proteins in the body that affect some immune cells) in
      HIV-infected children who are beginning or changing anti-HIV therapy.

      Though studies have been done on adults, little is known about the effects of HIV infection
      and anti-HIV drugs on body composition in children. One theory is that changes in body
      composition can predict the failure of anti-HIV treatment. If this is true, body composition
      measurements can be as useful as CD4+ cell counts in determining drug effectiveness.
    

Detailed Description

      Despite accumulating data in adults, little information is available regarding the effects of
      HIV infection and antiretroviral therapy on body composition in children. Preliminary
      information indicates that lean body mass is lost in preference to fat mass in HIV-infected
      children, supporting the theory that failure to thrive in HIV infection is often cytokine
      mediated. It can be hypothesized that changes in body composition (lean body mass) may
      predict changes in weight growth velocity and may give an early clinical indication of
      treatment failure. If so, body composition measurement may yield an additional outcome
      measure for clinical trials, equivalent in utility to other laboratory measures of treatment
      response, e.g., persistent CD4+ cell count changes. Additionally, if body composition changes
      are highly correlated with responses in viral load, body composition may prove to be a more
      affordable measure of antiretroviral effectiveness in developing countries.

      This study is a nonrandomized, observational study. Children are recruited to each of 4 age
      strata:

      Stratum A: 1 month to 18 months. Stratum B: greater than 18 months to 3 years. Stratum C:
      greater than 3 years to 8 years. Stratum D: greater than 8 years to less than 13 years.
      Children beginning or changing antiretroviral therapy and fulfilling the study specifications
      may be enrolled in the study. Children have 5 outpatient clinic visits, at entry and at 12,
      24, 36, and 48 weeks, for anthropometry, body composition by bioelectrical impedance
      analysis, cytokine levels, viral load, CD4+ cell count, and markers of lipid and glucose
      metabolism.
    


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

100

Start Date

June 2000

Completion Date

February 2005


Eligibility Criteria

        Inclusion Criteria

        Children may be eligible for this study if they:

          -  Are 1 month to 12 years old.

          -  Are HIV-1 positive.

          -  Have not begun puberty.

          -  Are beginning or changing anti-HIV therapy and:

          -  (1) have never used anti-HIV drugs and are starting any anti-HIV therapy; or (2) have
             never used protease inhibitors (PIs) and are starting a PI-containing therapy; or (3)
             have used PIs in the past and are changing anti-HIV treatment and have never used at
             least 2 of the drugs in the new therapy.

          -  Have a parent or legal guardian able and willing to provide signed informed consent.

        Exclusion Criteria

        Children will not be eligible for this study if they:

          -  Have cancer.

          -  Use metal artificial body parts or electrical devices that have been inserted into the
             body (such as a pacemaker).

          -  Have had an arm or leg removed.

          -  Have a physical disability that would prevent an accurate measurement of body height
             or length.

          -  Have diabetes and need insulin.

          -  Have or have had a serious illness or fever in the 14 days before entering study
             (except an upper respiratory infection without a fever).

          -  Have used steroids (corticosteroids, anabolic steroids, or megestrol acetate),
             interleukin, interferon, thalidomide, or GH within 180 days before entering study.
             Glucocorticoids are allowed as long as treatment did not occur during the 14 days
             before entering study and total treatment in the 180 days before entering study was
             not more than 15 days.

          -  Have used anti-HIV medication, if they are beginning any anti-HIV therapy.

          -  Have used PIs, if they are beginning a PI-containing regimen. (Prior use of PIs is
             allowed if child is changing anti-HIV treatment and he/she has never used at least 2
             of the drugs in the new therapy.)
      

Gender

All

Ages

1 Month - 12 Years

Accepts Healthy Volunteers

No

Contacts

Caroline Chantry, , 

Location Countries

Puerto Rico

Location Countries

Puerto Rico

Administrative Informations


NCT ID

NCT00006064

Organization ID

P1010

Secondary IDs

10814

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

Caroline Chantry, Study Chair, 


Verification Date

October 2014