HIV Infections Clinical Trial
Official title:
Pediatric Late Outcomes Protocol
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.
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. |
N/A
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 |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States, Puerto Rico,
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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