HIV InfectionsNCT00006064
The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
An observational study of HIV Infections and HIV Wasting Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- HIV Infections, HIV Wasting Syndrome, Lipodystrophy
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2000to Feb 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 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Texas Children's Hosp. CRS
Houston, Texas, 77030
Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, 10461
Puerto Rico1 site
University of Puerto Rico Pediatric HIV/AIDS Research Program CRS
San Juan, PR, 00935
About this study
Official title: Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children
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.
Read the 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.
- Conditions
- HIV Infections, HIV Wasting Syndrome, Lipodystrophy
- Keywords
- Tumor Necrosis Factor, CD4 Lymphocyte Count, Polymerase Chain Reaction, Enzyme-Linked Immunosorbent Assay, RNA, Messenger, Interleukin-1, Body Composition, Anti-HIV Agents, Viral Load, Age Factors, Anthropometry
- Medical subject headings
- HIV Infections, HIV Wasting Syndrome, Lipodystrophy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startJun 2000
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Enrolment
- 100 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Caroline Chantry, Study chairJoseph Cervia, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006064
- Sponsor's protocol ID
- P1010
- Other IDs
- 10814, PACTG P1010, ACTG P1010
- Status last verified
- Oct 2014
- First submitted
- 16 Jun 2000
- Last updated
- 29 Oct 2014
- Results posted
- No
Publications
Chantry CJ, Hughes MD, Alvero C, Cervia JS, Hodge J, Borum P, Moye J Jr; PACTG 1010 Team. Insulin-like growth factor-1 and lean body mass in HIV-infected children. J Acquir Immune Defic Syndr. 2008 Aug 1;48(4):437-43. doi: 10.1097/QAI.0b013e31817bbe6d.
PubMed 18614924Chantry CJ, Hughes MD, Alvero C, Cervia JS, Meyer WA 3rd, Hodge J, Borum P, Moye J Jr; PACTG 1010 Team. Lipid and glucose alterations in HIV-infected children beginning or changing antiretroviral therapy. Pediatrics. 2008 Jul;122(1):e129-38. doi: 10.1542/peds.2007-2467. Epub 2008 Jun 2.
PubMed 18519448Chantry CJ, Cervia JS, Hughes MD, Alvero C, Hodge J, Borum P, Moye J Jr; PACTG 1010 Team. Predictors of growth and body composition in HIV-infected children beginning or changing antiretroviral therapy. HIV Med. 2010 Oct 1;11(9):573-83. doi: 10.1111/j.1468-1293.2010.00823.x. Epub 2010 Mar 21.
PubMed 20345880Cervia JS, Chantry CJ, Hughes MD, Alvero C, Meyer WA 3rd, Hodge J, Borum P, Moye J Jr, Spector SA; PACTG 1010 Team. Associations of proinflammatory cytokine levels with lipid profiles, growth, and body composition in HIV-infected children initiating or changing antiretroviral therapy. Pediatr Infect Dis J. 2010 Dec;29(12):1118-22. doi: 10.1097/INF.0b013e3181ed9f4c.
PubMed 20631646
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children
- ClinicalTrials.gov ID
- NCT00006064
- Acronym / sponsor ID
- P1010
- Conditions
- HIV Infections, HIV Wasting Syndrome, Lipodystrophy
- Keywords
- Tumor Necrosis Factor, CD4 Lymphocyte Count, Polymerase Chain Reaction, Enzyme-Linked Immunosorbent Assay, RNA, Messenger, Interleukin-1, Body Composition, Anti-HIV Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2000
- Study completion
- Feb 2005 (actual)
- First posted
- 31 Aug 2001 (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.
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 design
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 29 Oct 2014.
- Results publication: PubMed 18614924Chantry CJ, Hughes MD, Alvero C, Cervia JS, Hodge J, Borum P, Moye J Jr; PACTG 1010 Team. Insulin-like growth factor-1 and lean body mass in HIV-infected children. J Acquir Immune Defic Syndr. 2008 Aug 1;48(4):437-43. doi: 10.1097/QAI.0b013e31817bbe6d.
- Results publication: PubMed 18519448Chantry CJ, Hughes MD, Alvero C, Cervia JS, Meyer WA 3rd, Hodge J, Borum P, Moye J Jr; PACTG 1010 Team. Lipid and glucose alterations in HIV-infected children beginning or changing antiretroviral therapy. Pediatrics. 2008 Jul;122(1):e129-38. doi: 10.1542/peds.2007-2467. Epub 2008 Jun 2.
- Results publication: PubMed 20345880Chantry CJ, Cervia JS, Hughes MD, Alvero C, Hodge J, Borum P, Moye J Jr; PACTG 1010 Team. Predictors of growth and body composition in HIV-infected children beginning or changing antiretroviral therapy. HIV Med. 2010 Oct 1;11(9):573-83. doi: 10.1111/j.1468-1293.2010.00823.x. Epub 2010 Mar 21.
- Results publication: PubMed 20631646Cervia JS, Chantry CJ, Hughes MD, Alvero C, Meyer WA 3rd, Hodge J, Borum P, Moye J Jr, Spector SA; PACTG 1010 Team. Associations of proinflammatory cytokine levels with lipid profiles, growth, and body composition in HIV-infected children initiating or changing antiretroviral therapy. Pediatr Infect Dis J. 2010 Dec;29(12):1118-22. doi: 10.1097/INF.0b013e3181ed9f4c.
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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.
Caroline Chantry study chair
Joseph Cervia study chair
3 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 and HIV Wasting Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 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 7 inclusion and 10 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 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 NCT00006064, which also lists 4 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 29 Oct 2014.