Long-Term Effects of HIV Exposure and Infection in Children
NCT ID: NCT00006304
Last Updated: 2013-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
4150 participants
OBSERVATIONAL
2002-05-31
Brief Summary
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Detailed Description
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Children in this study will include patients who are HIV infected, were exposed to HIV or anti-HIV drugs prior to or at the time of their birth, or children of patients followed at Pediatric AIDS Clinical Trial Group (PACTG) sites. Children will have a study visit every 3 months through the first year of life. After age 1, children who are HIV infected will continue to have study visits every 3 months, while children who are HIV uninfected will have study visits once a year. Study assessments will include complete physical exam, medical history, Tanner staging, neurologic exam, growth and quality of life assessments, and laboratory tests such as hematology, chemistries, and urinalysis. Not all assessments will be performed at each study visit. Patients will be followed until age 24.
Conditions
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Keywords
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Eligibility Criteria
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Inclusion Criteria
* Meet 1 of the following 3 requirements: 1) enrolled in a previous version of this study; 2) perinatally exposed to HIV, HIV vaccines, or antiretroviral treatment (must enroll before first birthday); 3) HIV infected infants, children, and adolescents (and their offspring) followed at PACTG sites.
Exclusion Criteria
24 Hours
21 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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James Oleske
Role: STUDY_CHAIR
Michael Brady
Role: STUDY_CHAIR
Wayne Dankner
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States
Univ of South Alabama
Mobile, Alabama, United States
Phoenix Childrens Hosp
Phoenix, Arizona, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States
Long Beach Memorial (Pediatric)
Long Beach, California, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, United States
UCLA Med Ctr / Pediatrics
Los Angeles, California, United States
UCLA Med Ctr
Los Angeles, California, United States
Children's Hosp of Oakland
Oakland, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Connecticut Children's Med Ctr
Farmington, Connecticut, United States
Univ of Connecticut / Farmington
Farmington, Connecticut, United States
Yale Univ Med School
New Haven, Connecticut, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States
North Broward Hosp District
Fort Lauderdale, Florida, United States
Univ of Florida Gainesville
Gainesville, Florida, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Sacred Heart Children's Hosp / CMS of Florida
Pensacola, Florida, United States
Palm Beach County Health Dept
Riviera Beach, Florida, United States
Univ of South Florida
St. Petersburg, Florida, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States
Med College of Georgia
Augusta, Georgia, United States
The Med Ctr Inc
Columbus, Georgia, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, United States
Cook County Hosp
Chicago, Illinois, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States
Earl K Long Early Intervention Clinic
New Orleans, Louisiana, United States
Univ Hosp
New Orleans, Louisiana, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
Childrens Hospital of Boston
Boston, Massachusetts, United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, United States
Children's Hosp of Michigan
Detroit, Michigan, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States
St. Louis Children's Hosp
St Louis, Missouri, United States
Cooper Hosp
Camden, New Jersey, United States
Robert Wood Johnson AIDS Program
New Brunswick, New Jersey, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States
Children's Hosp at Albany Med Ctr
Albany, New York, United States
SUNY - Brooklyn
Brooklyn, New York, United States
North Shore Univ Hosp
Great Neck, New York, United States
Schneider Children's Hosp
New Hyde Park, New York, United States
Beth Israel Med Ctr / Pediatrics
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Cornell Univ Med College
New York, New York, United States
New York Hosp - Cornell Med Ctr
New York, New York, United States
Metropolitan Hosp Ctr
New York, New York, United States
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States
Harlem Hosp Ctr
New York, New York, United States
Univ of Rochester Med Ctr
Rochester, New York, United States
State Univ of New York at Stony Brook
Stony Brook, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States
Montefiore Medical / AECOM
The Bronx, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, United States
Columbus Children's Hosp
Columbus, Ohio, United States
Oregon Health Sciences Univ
Portland, Oregon, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States
Children's Med Ctr of Dallas
Dallas, Texas, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, United States
Med College of Virginia
Richmond, Virginia, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, , Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , Puerto Rico
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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References
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Brady MT, Clark C, Weedy C, Fowler M, Mofenson L, Oleske J. Disclosure of HIV diagnosis to children in ACTG clinical trials (ACTG 219). Int Conf AIDS. 1996 Jul 7-12;11(2):43 (abstract no WeD131)
Gaughan DM, Mofeson LM, Hughes MD, Seage GR, Oleske JM. Avascular necrosis of the hip (Leggs-Calve-Perthes disease [LCPD]) in HIV-infected children in long-term follow-up: PACTG study 219. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 638)
Buchacz K, Cervia JS, Lindsey JC, Hughes MD, Seage GR 3rd, Dankner WM, Oleske JM, Moye J. Impact of protease inhibitor-containing combination antiretroviral therapies on height and weight growth in HIV-infected children. Pediatrics. 2001 Oct;108(4):E72. doi: 10.1542/peds.108.4.e72.
Culnane M, Fowler M, Lee SS, McSherry G, Brady M, O'Donnell K, Mofenson L, Gortmaker SL, Shapiro DE, Scott G, Jimenez E, Moore EC, Diaz C, Flynn PM, Cunningham B, Oleske J. Lack of long-term effects of in utero exposure to zidovudine among uninfected children born to HIV-infected women. Pediatric AIDS Clinical Trials Group Protocol 219/076 Teams. JAMA. 1999 Jan 13;281(2):151-7. doi: 10.1001/jama.281.2.151.
Gaughan DM, Mofenson LM, Hughes MD, Seage GR 3rd, Ciupak GL, Oleske JM; Pediatric AIDS Clinical Trials Group Protocol 219 Team. Osteonecrosis of the hip (Legg-Calve-Perthes disease) in human immunodeficiency virus-infected children. Pediatrics. 2002 May;109(5):E74-4. doi: 10.1542/peds.109.5.e74.
Hanson IC, Antonelli TA, Sperling RS, Oleske JM, Cooper E, Culnane M, Fowler MG, Kalish LA, Lee SS, McSherry G, Mofenson L, Shapiro DE. Lack of tumors in infants with perinatal HIV-1 exposure and fetal/neonatal exposure to zidovudine. J Acquir Immune Defic Syndr Hum Retrovirol. 1999 Apr 15;20(5):463-7. doi: 10.1097/00042560-199904150-00008.
Gaughan DM, Hughes MD, Seage GR 3rd, Selwyn PA, Carey VJ, Gortmaker SL, Oleske JM. The prevalence of pain in pediatric human immunodeficiency virus/acquired immunodeficiency syndrome as reported by participants in the Pediatric Late Outcomes Study (PACTG 219). Pediatrics. 2002 Jun;109(6):1144-52. doi: 10.1542/peds.109.6.1144.
Gortmaker SL, Hughes M, Cervia J, Brady M, Johnson GM, Seage GR 3rd, Song LY, Dankner WM, Oleske JM; Pediatric AIDS Clinical Trials Group Protocol 219 Team. Effect of combination therapy including protease inhibitors on mortality among children and adolescents infected with HIV-1. N Engl J Med. 2001 Nov 22;345(21):1522-8. doi: 10.1056/NEJMoa011157.
Howland LC, Gortmaker SL, Mofenson LM, Spino C, Gardner JD, Gorski H, Fowler MG, Oleske J. Effects of negative life events on immune suppression in children and youth infected with human immunodeficiency virus type 1. Pediatrics. 2000 Sep;106(3):540-6. doi: 10.1542/peds.106.3.540.
Nucleoside exposure in the children of HIV-infected women receiving antiretroviral drugs: absence of clear evidence for mitochondrial disease in children who died before 5 years of age in five United States cohorts. J Acquir Immune Defic Syndr. 2000 Nov 1;25(3):261-8. doi: 10.1097/00126334-200011010-00009.
Gaughan DM, Hughes MD, Oleske JM, Malee K, Gore CA, Nachman S; Pediatric AIDS Clinical Trials Group 219C Team. Psychiatric hospitalizations among children and youths with human immunodeficiency virus infection. Pediatrics. 2004 Jun;113(6):e544-51. doi: 10.1542/peds.113.6.e544.
Farley J, Gona P, Crain M, Cervia J, Oleske J, Seage G, Lindsey J; Pediatric AIDS Clinical Trials Group Study 219C Team. Prevalence of elevated cholesterol and associated risk factors among perinatally HIV-infected children (4-19 years old) in Pediatric AIDS Clinical Trials Group 219C. J Acquir Immune Defic Syndr. 2005 Apr 1;38(4):480-7. doi: 10.1097/01.qai.0000139397.30612.96.
Kest H, Brogly S, McSherry G, Dashefsky B, Oleske J, Seage GR 3rd. Malignancy in perinatally human immunodeficiency virus-infected children in the United States. Pediatr Infect Dis J. 2005 Mar;24(3):237-42. doi: 10.1097/01.inf.0000154324.59426.8d.
Brogly S, Williams P, Seage GR 3rd, Oleske JM, Van Dyke R, McIntosh K; PACTG 219C Team. Antiretroviral treatment in pediatric HIV infection in the United States: from clinical trials to clinical practice. JAMA. 2005 May 11;293(18):2213-20. doi: 10.1001/jama.293.18.2213.
Gona P, Van Dyke RB, Williams PL, Dankner WM, Chernoff MC, Nachman SA, Seage GR 3rd. Incidence of opportunistic and other infections in HIV-infected children in the HAART era. JAMA. 2006 Jul 19;296(3):292-300. doi: 10.1001/jama.296.3.292.
Williams PL, Storm D, Montepiedra G, Nichols S, Kammerer B, Sirois PA, Farley J, Malee K; PACTG 219C Team. Predictors of adherence to antiretroviral medications in children and adolescents with HIV infection. Pediatrics. 2006 Dec;118(6):e1745-57. doi: 10.1542/peds.2006-0493. Epub 2006 Nov 13.
Sirois PA, Montepiedra G, Kapetanovic S, Williams PL, Pearson DA, Malee K, Garvie PA, Kammerer BL, Nichols SL, Nozyce ML, Mintz M, Mitchell WG, Oleske JM; IMPAACT/PACTG 219C Team. Impact of medications prescribed for treatment of attention-deficit hyperactivity disorder on physical growth in children and adolescents with HIV. J Dev Behav Pediatr. 2009 Oct;30(5):403-12. doi: 10.1097/dbp.0b013e3181ba0cf6.
Levin MJ, Anderson JP, Seage GR 3rd, Williams PL; PACTG/IMPAACT 219C Team. Short-term and long-term effects of highly active antiretroviral therapy on the incidence of herpes zoster in HIV-infected children. J Acquir Immune Defic Syndr. 2009 Feb 1;50(2):182-91. doi: 10.1097/QAI.0b013e31819550a4.
Edathodu J, Halim MM, Dahham MB, Alrajhi AA. Mother-to-child transmission of HIV: experience at a referral hospital in Saudi Arabia. Ann Saudi Med. 2010 Jan-Feb;30(1):15-7. doi: 10.4103/0256-4947.59367.
Kapetanovic S, Aaron L, Montepiedra G, Sirois PA, Oleske JM, Malee K, Pearson DA, Nichols SL, Garvie PA, Farley J, Nozyce ML, Mintz M, Williams PL; Pediatric AIDS Clinical Trials. The use of second-generation antipsychotics and the changes in physical growth in children and adolescents with perinatally acquired HIV. AIDS Patient Care STDS. 2009 Nov;23(11):939-47. doi: 10.1089/apc.2009.0121.
Nachman SA, Chernoff M, Gona P, Van Dyke RB, Dankner WM, Seage GR 3rd, Oleske J, Williams PL; PACTG 219C Team. Incidence of noninfectious conditions in perinatally HIV-infected children and adolescents in the HAART era. Arch Pediatr Adolesc Med. 2009 Feb;163(2):164-71. doi: 10.1001/archpedi.163.2.164.
Williams PL, Van Dyke R, Eagle M, Smith D, Vincent C, Ciupak G, Oleske J, Seage GR 3rd; PACTG 219C Team. Association of site-specific and participant-specific factors with retention of children in a long-term pediatric HIV cohort study. Am J Epidemiol. 2008 Jun 1;167(11):1375-86. doi: 10.1093/aje/kwn072. Epub 2008 Apr 15.
Lyon ME, Williams PL, Woods ER, Hutton N, Butler AM, Sibinga E, Brady MT, Oleske JM. Do-not-resuscitate orders and/or hospice care, psychological health, and quality of life among children/adolescents with acquired immune deficiency syndrome. J Palliat Med. 2008 Apr;11(3):459-69. doi: 10.1089/jpm.2007.0148.
Lindsey JC, Malee KM, Brouwers P, Hughes MD; PACTG 219C Study Team. Neurodevelopmental functioning in HIV-infected infants and young children before and after the introduction of protease inhibitor-based highly active antiretroviral therapy. Pediatrics. 2007 Mar;119(3):e681-93. doi: 10.1542/peds.2006-1145. Epub 2007 Feb 12.
Seage GR 3rd, Buchacz K, Weinberg GA, Patel K, McIntosh K, Dankner WM. The Pediatric AIDS Severity Score (PASS): a multidimensional AIDS-severity adjustment for pediatric HIV infection. J Acquir Immune Defic Syndr. 2006 Dec 15;43(5):603-10. doi: 10.1097/01.qai.0000242453.20521.4f.
Williams PL, Marino M, Malee K, Brogly S, Hughes MD, Mofenson LM; PACTG 219C Team. Neurodevelopment and in utero antiretroviral exposure of HIV-exposed uninfected infants. Pediatrics. 2010 Feb;125(2):e250-60. doi: 10.1542/peds.2009-1112. Epub 2010 Jan 18.
Malee K, Williams PL, Montepiedra G, Nichols S, Sirois PA, Storm D, Farley J, Kammerer B; PACTG 219C Team. The role of cognitive functioning in medication adherence of children and adolescents with HIV infection. J Pediatr Psychol. 2009 Mar;34(2):164-75. doi: 10.1093/jpepsy/jsn068. Epub 2008 Jul 22.
Kapetanovic S, Aaron L, Williams PL, Farley J, Sirois PA, Garvie PA, Pearson DA, Oleske JM, Montepiedra G; The IMPAACT PACTG 219C Team. Relationships between the use of second-generation antipsychotics and changes in total cholesterol levels in children and adolescents perinatally infected with HIV. Neurobehav HIV Med. 2010 Aug;2010(2):39-48. doi: 10.2147/NBHIV.S12517.
Malee K, Williams P, Montepiedra G, McCabe M, Nichols S, Sirois PA, Storm D, Farley J, Kammerer B; PACTG 219C Team. Medication adherence in children and adolescents with HIV infection: associations with behavioral impairment. AIDS Patient Care STDS. 2011 Mar;25(3):191-200. doi: 10.1089/apc.2010.0181. Epub 2011 Feb 16.
Other Identifiers
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ACTG 219
Identifier Type: -
Identifier Source: secondary_id
PACTG 219C
Identifier Type: -
Identifier Source: secondary_id
11196
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 219C
Identifier Type: -
Identifier Source: org_study_id
NCT00000786
Identifier Type: -
Identifier Source: nct_alias