- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00006304
Langtidseffekter av HIV-eksponering og -infeksjon hos barn
Pediatrisk sene utfallsprotokoll
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Potensielle langsiktige fordeler, toksisiteter og andre uheldige utfall av nye anti-HIV-terapier kan ikke vurderes innenfor tidsrammen for de fleste kliniske studier. Det er behov for å bedre vurdere både positive og negative senutfall og sen behandlingseffekt hos barn i vekst. Denne prospektive, longitudinelle studien vil evaluere effekten og deres innvirkning på barn.
Barn i denne studien vil inkludere pasienter som er HIV-smittet, ble eksponert for HIV- eller anti-HIV-legemidler før eller ved fødselen, eller barn av pasienter som følges på Pediatric AIDS Clinical Trial Group (PACTG). Barn skal ha studiebesøk hver 3. måned gjennom første leveår. Etter 1 års alder vil barn som er HIV-smittet fortsette å ha studiebesøk hver 3. måned, mens barn som er HIV-uinfisert vil ha studiebesøk en gang i året. Studievurderinger vil inkludere fullstendig fysisk undersøkelse, medisinsk historie, Tanner-stadie, nevrologisk undersøkelse, vekst og livskvalitetsvurderinger, og laboratorietester som hematologi, kjemi og urinanalyse. Ikke alle vurderinger vil bli utført ved hvert studiebesøk. Pasienter vil bli fulgt frem til 24 år.
Studietype
Registrering
Kontakter og plasseringer
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35233
- Univ of Alabama at Birmingham - Pediatric
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Mobile, Alabama, Forente stater, 36604
- Univ of South Alabama
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Arizona
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Phoenix, Arizona, Forente stater, 85006
- Phoenix Childrens Hosp
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California
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La Jolla, California, Forente stater, 920930672
- UCSD Med Ctr / Pediatrics / Clinical Sciences
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Long Beach, California, Forente stater, 90801
- Long Beach Memorial (Pediatric)
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Los Angeles, California, Forente stater, 900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
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Los Angeles, California, Forente stater, 90033
- Los Angeles County - USC Med Ctr
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Los Angeles, California, Forente stater, 900481804
- Cedars Sinai / UCLA Med Ctr
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Los Angeles, California, Forente stater, 900951752
- UCLA Med Ctr / Pediatric
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Los Angeles, California, Forente stater, 90095
- UCLA Med Ctr / Pediatrics
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Los Angeles, California, Forente stater, 90095
- UCLA Med Ctr
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Oakland, California, Forente stater, 946091809
- Children's Hosp of Oakland
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San Francisco, California, Forente stater, 94110
- San Francisco Gen Hosp
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San Francisco, California, Forente stater, 941430105
- UCSF / Moffitt Hosp - Pediatric
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Connecticut
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Farmington, Connecticut, Forente stater, 06032
- Univ of Connecticut / Farmington
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Farmington, Connecticut, Forente stater, 060303805
- Connecticut Children's Med Ctr
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New Haven, Connecticut, Forente stater, 06504
- Yale Univ Med School
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District of Columbia
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Washington, District of Columbia, Forente stater, 20060
- Howard Univ. Washington DC NICHD CRS
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Washington, District of Columbia, Forente stater, 200102916
- Children's Hosp of Washington DC
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Florida
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Fort Lauderdale, Florida, Forente stater, 33311
- North Broward Hosp District
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Gainesville, Florida, Forente stater, 32610
- Univ of Florida Gainesville
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Jacksonville, Florida, Forente stater, 32209
- Univ of Florida Health Science Ctr / Pediatrics
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Miami, Florida, Forente stater, 33161
- Univ of Miami (Pediatric)
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Miami, Florida, Forente stater, 33136
- Univ of Miami / Jackson Memorial Hosp
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Pensacola, Florida, Forente stater, 32503
- Sacred Heart Children's Hosp / CMS of Florida
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Riviera Beach, Florida, Forente stater, 33404
- Palm Beach County Health Dept
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St. Petersburg, Florida, Forente stater, 33701
- Univ of South Florida
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Georgia
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Atlanta, Georgia, Forente stater, 30306
- Emory Univ Hosp / Pediatrics
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Augusta, Georgia, Forente stater, 30912
- Med College of Georgia
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Columbus, Georgia, Forente stater, 31901
- The Med Ctr Inc
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Cook County Hosp
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Chicago, Illinois, Forente stater, 606143394
- Chicago Children's Memorial Hosp
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Chicago, Illinois, Forente stater, 606371470
- Univ of Chicago Children's Hosp
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Chicago, Illinois, Forente stater, 60612
- Univ of Illinois College of Medicine / Pediatrics
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Chicago, Illinois, Forente stater, 60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
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Louisiana
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New Orleans, Louisiana, Forente stater, 701122699
- Tulane Univ / Charity Hosp of New Orleans
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New Orleans, Louisiana, Forente stater, 70112-2699
- Children's Hospital of New Orleans
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New Orleans, Louisiana, Forente stater, 70112
- Earl K Long Early Intervention Clinic
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New Orleans, Louisiana, Forente stater, 70112
- Univ Hosp
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Univ of Maryland at Baltimore / Univ Med Ctr
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Baltimore, Maryland, Forente stater, 212874933
- Johns Hopkins Hosp - Pediatric
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Massachusetts
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Boston, Massachusetts, Forente stater, 021155724
- Children's Hosp of Boston
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Boston, Massachusetts, Forente stater, 02118
- Boston City Hosp / Pediatrics
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Boston, Massachusetts, Forente stater, 02115
- Childrens Hospital of Boston
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Springfield, Massachusetts, Forente stater, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, Forente stater, 016550001
- Univ of Massachusetts Med School
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Michigan
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Detroit, Michigan, Forente stater, 48201
- Children's Hosp of Michigan
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Mississippi
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Jackson, Mississippi, Forente stater, 39213
- Univ of Mississippi Med Ctr
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Missouri
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St. Louis, Missouri, Forente stater, 63110
- St. Louis Children's Hosp
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New Jersey
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Camden, New Jersey, Forente stater, 081031438
- Cooper Hosp
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New Brunswick, New Jersey, Forente stater, 089030019
- UMDNJ - Robert Wood Johnson Med School / Pediatrics
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New Brunswick, New Jersey, Forente stater, 08901-1969
- Robert Wood Johnson AIDS Program
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Newark, New Jersey, Forente stater, 071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
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Newark, New Jersey, Forente stater, 07103
- Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
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New York
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Albany, New York, Forente stater, 12208
- Children's Hosp at Albany Med Ctr
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Bronx, New York, Forente stater, 10461
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
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Bronx, New York, Forente stater, 10467
- Montefiore Med Ctr Adolescent AIDS Program
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Bronx, New York, Forente stater, 10457
- Bronx Lebanon Hosp Ctr
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Bronx, New York, Forente stater, 19461
- Montefiore Medical / AECOM
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Brooklyn, New York, Forente stater, 11203
- SUNY - Brooklyn
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Great Neck, New York, Forente stater, 11021
- North Shore Univ Hosp
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New Hyde Park, New York, Forente stater, 11040
- Schneider Children's Hosp
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New York, New York, Forente stater, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, Forente stater, 10029
- Metropolitan Hosp Ctr
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New York, New York, Forente stater, 10021
- Cornell Univ Med College
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New York, New York, Forente stater, 10032
- Columbia Presbyterian Med Ctr
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New York, New York, Forente stater, 10032
- Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
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New York, New York, Forente stater, 10037
- Harlem Hosp Ctr
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New York, New York, Forente stater, 10029
- Mount Sinai Med Ctr / Pediatrics
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New York, New York, Forente stater, 10021
- New York Hosp - Cornell Med Ctr
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New York, New York, Forente stater, 10003
- Beth Israel Med Ctr / Pediatrics
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Rochester, New York, Forente stater, 146420001
- Univ of Rochester Med Ctr
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Stony Brook, New York, Forente stater, 117948111
- State Univ of New York at Stony Brook
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Syracuse, New York, Forente stater, 13210
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
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North Carolina
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Durham, North Carolina, Forente stater, 277103499
- Duke Univ Med Ctr
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Durham, North Carolina, Forente stater, 27710
- Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
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Ohio
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Columbus, Ohio, Forente stater, 432052696
- Columbus Children's Hosp
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Oregon
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Portland, Oregon, Forente stater, 97201
- Oregon Health Sciences Univ
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 191044318
- Children's Hosp of Philadelphia
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Philadelphia, Pennsylvania, Forente stater, 191341095
- Saint Christopher's Hosp for Children
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Rhode Island
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Providence, Rhode Island, Forente stater, 02903
- Rhode Island Hosp / Brown Univ
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South Carolina
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Charleston, South Carolina, Forente stater, 294253312
- Med Univ of South Carolina
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Tennessee
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Memphis, Tennessee, Forente stater, 381052794
- Saint Jude Children's Research Hosp of Memphis
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Nashville, Tennessee, Forente stater, 372322581
- Vanderbilt Univ Med Ctr
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Texas
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Dallas, Texas, Forente stater, 75235
- Children's Med Ctr of Dallas
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Houston, Texas, Forente stater, 77030
- Texas Children's Hosp / Baylor Univ
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Virginia
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Norfolk, Virginia, Forente stater, 23507
- Children's Hosp of the King's Daughters
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Richmond, Virginia, Forente stater, 23219
- Med College of Virginia
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Washington
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Seattle, Washington, Forente stater, 981050371
- Children's Hospital & Medical Center / Seattle ACTU
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Bayamon, Puerto Rico, 00956
- Ramon Ruiz Arnau Univ Hosp / Pediatrics
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San Juan, Puerto Rico, 009367344
- San Juan City Hosp
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San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico / Univ Children's Hosp AIDS
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inklusjonskriterier
- Alder 21 eller yngre (samtykke fra foreldre eller foresatte kreves hvis under 18).
- Oppfyll 1 av følgende 3 krav: 1) registrert i en tidligere versjon av denne studien; 2) perinatalt eksponert for HIV, HIV-vaksiner eller antiretroviral behandling (må registreres før første bursdag); 3) HIV-infiserte spedbarn, barn og ungdom (og deres avkom) fulgte på PACTG-steder.
Eksklusjonskriterier
- Kan ikke overholde tidsplaner for studiebesøk.
Studieplan
Hvordan er studiet utformet?
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: James Oleske
- Studiestol: Michael Brady
- Studiestol: Wayne Dankner
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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. Erratum In: Arch Pediatr Adolesc Med. 2009 Apr;163(4):364.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACTG 219C
- ACTG 219
- PACTG 219C
- 11196 (Registeridentifikator: DAIDS ES)
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