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NCT00006304 Clinical Trial

Long-Term Effects of HIV Exposure and Infection in Children

HIV Infections Clinical Trial

Official title:
Pediatric Late Outcomes Protocol

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00006304
Other study ID # ACTG 219C
Secondary ID ACTG 219PACTG 21
Status Completed
Phase N/A
First received September 27, 2000
Last updated October 4, 2013
Est. completion date May 2002

Study information
Verified date October 2013
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

As new drugs and vaccines are developed to prevent HIV disease progression and prolong survival of HIV infected patients, the short-term safety and effectiveness of these treatments are evaluated in research studies. However, the long-term effects, whether they are benefits or side effects, need to be studied as well. These long-term effects may have a greater impact on infants and children who are still growing and developing. The purpose of this study is to follow HIV-exposed and HIV infected infants, children, and adolescents who are seen at Pediatric AIDS Clinical Trials Group (PACTG) study sites. These patients will be observed for long-term benefits or any late harmful effects of medications or vaccines.

Description:

The potential long-term benefits, toxicities, and other adverse outcomes of new anti-HIV therapies cannot be assessed within the time frame of most clinical trials. There is a need to better assess both positive and negative late outcomes and late treatment effects in growing children. This prospective, longitudinal study will evaluate the effects and their impact on children.

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.

Other known NCT identifiers
  • NCT00000786

Recruitment information / eligibility
Status Completed
Enrollment 4150
Est. completion date May 2002
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 21 Years
Eligibility Inclusion Criteria

- Age 21 or younger (consent of parent or guardian required if under 18).

- 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

- Unable to adhere to study visit schedules.

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico Ramon Ruiz Arnau Univ Hosp / Pediatrics Bayamon
Puerto Rico San Juan City Hosp San Juan
Puerto Rico Univ of Puerto Rico / Univ Children's Hosp AIDS San Juan
United States Children's Hosp at Albany Med Ctr Albany New York
United States Emory Univ Hosp / Pediatrics Atlanta Georgia
United States Med College of Georgia Augusta Georgia
United States Johns Hopkins Hosp - Pediatric Baltimore Maryland
United States Univ of Maryland at Baltimore / Univ Med Ctr Baltimore Maryland
United States Univ of Alabama at Birmingham - Pediatric Birmingham Alabama
United States Boston City Hosp / Pediatrics Boston Massachusetts
United States Children's Hosp of Boston Boston Massachusetts
United States Childrens Hospital of Boston Boston Massachusetts
United States Bronx Lebanon Hosp Ctr Bronx New York
United States Bronx Municipal Hosp Ctr/Jacobi Med Ctr Bronx New York
United States Montefiore Med Ctr Adolescent AIDS Program Bronx New York
United States Montefiore Medical / AECOM Bronx New York
United States SUNY - Brooklyn Brooklyn New York
United States Cooper Hosp Camden New Jersey
United States Med Univ of South Carolina Charleston South Carolina
United States Chicago Children's Memorial Hosp Chicago Illinois
United States Cook County Hosp Chicago Illinois
United States Mt Sinai Hosp Med Ctr / Dept of Pediatrics Chicago Illinois
United States Univ of Chicago Children's Hosp Chicago Illinois
United States Univ of Illinois College of Medicine / Pediatrics Chicago Illinois
United States Columbus Children's Hosp Columbus Ohio
United States The Med Ctr Inc Columbus Georgia
United States Children's Med Ctr of Dallas Dallas Texas
United States Children's Hosp of Michigan Detroit Michigan
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 Connecticut Children's Med Ctr Farmington Connecticut
United States Univ of Connecticut / Farmington Farmington Connecticut
United States North Broward Hosp District Fort Lauderdale Florida
United States Univ of Florida Gainesville Gainesville Florida
United States North Shore Univ Hosp Great Neck New York
United States Texas Children's Hosp / Baylor Univ Houston Texas
United States Univ of Mississippi Med Ctr Jackson Mississippi
United States Univ of Florida Health Science Ctr / Pediatrics Jacksonville Florida
United States UCSD Med Ctr / Pediatrics / Clinical Sciences La Jolla California
United States Long Beach Memorial (Pediatric) Long Beach California
United States Cedars Sinai / UCLA Med Ctr Los Angeles 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 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 Saint Jude Children's Research Hosp of Memphis Memphis Tennessee
United States Univ of Miami (Pediatric) Miami Florida
United States Univ of Miami / Jackson Memorial Hosp Miami Florida
United States Univ of South Alabama Mobile Alabama
United States Vanderbilt Univ Med Ctr Nashville Tennessee
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 Yale Univ Med School New Haven Connecticut
United States Schneider Children's Hosp New Hyde Park New York
United States Children's Hospital of New Orleans New Orleans Louisiana
United States Earl K Long Early Intervention Clinic New Orleans Louisiana
United States Tulane Univ / Charity Hosp of New Orleans New Orleans Louisiana
United States Univ Hosp New Orleans Louisiana
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Beth Israel Med Ctr / Pediatrics New York New York
United States Columbia Presbyterian Med Ctr New York New York
United States Cornell Univ Med College New York New York
United States Harlem Hosp Ctr New York New York
United States Incarnation Children's Ctr / Columbia Presbyterian 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 New York Hosp - Cornell Med Ctr New York New York
United States Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl Newark New Jersey
United States Univ of Medicine & Dentistry of New Jersey / Univ Hosp Newark New Jersey
United States Children's Hosp of the King's Daughters Norfolk Virginia
United States Children's Hosp of Oakland Oakland California
United States Sacred Heart Children's Hosp / CMS of Florida Pensacola Florida
United States Children's Hosp of Philadelphia Philadelphia Pennsylvania
United States Saint Christopher's Hosp for Children Philadelphia Pennsylvania
United States Phoenix Childrens Hosp Phoenix Arizona
United States Oregon Health Sciences Univ Portland Oregon
United States Rhode Island Hosp / Brown Univ Providence Rhode Island
United States Med College of Virginia Richmond Virginia
United States Palm Beach County Health Dept Riviera Beach Florida
United States Univ of Rochester Med Ctr Rochester New York
United States San Francisco Gen Hosp San Francisco California
United States UCSF / Moffitt Hosp - Pediatric San Francisco California
United States Children's Hospital & Medical Center / Seattle ACTU Seattle Washington
United States Baystate Med Ctr of Springfield Springfield Massachusetts
United States St. Louis Children's Hosp St. Louis Missouri
United States Univ of South Florida St. Petersburg Florida
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 Children's Hosp of Washington DC Washington District of Columbia
United States Howard Univ. Washington DC NICHD CRS Washington District of Columbia
United States Univ of Massachusetts Med School Worcester Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (29)

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)

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. — View Citation

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. — View Citation

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 chil — View Citation

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. — View Citation

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 A — View Citation

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. — View Citation

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 — View Citation

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-Calvé-Perthes disease) in human immunodeficiency virus-infected children. Pediatrics. 2002 May;1 — View Citation

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)

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. — View Citation

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 adoles — View Citation

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 Defi — View Citation

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. — View Citation

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 gro — View Citation

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 a — View Citation

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. — View Citation

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):1 — View Citation

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. 2 — View Citation

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 Me — View Citation

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 — View Citation

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. — View Citation

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; — View Citation

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 — View Citation

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. — View Citation

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 hyperac — View Citation

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. — View Citation

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. Epub 200 — View Citation

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. 20 — View Citation

* Note: There are 29 references in all — Click here to view all references

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