Adolescent Master Protocol (AMP)
This study is ongoing, but not recruiting participants.
Harvard School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Neurological Disorders and Stroke (NINDS)
Tulane University School of Medicine
National Institute of Dental and Craniofacial Research (NIDCR)
NIH Office of AIDS Research (OAR)
Information provided by (Responsible Party):
George Seage, Harvard School of Public Health
First received: July 22, 2011
Last updated: July 21, 2016
Last verified: July 2016
No Study Results Posted on ClinicalTrials.gov for this Study
|Study Status:||This study is ongoing, but not recruiting participants.|
|Estimated Study Completion Date:||July 2020|
|Estimated Primary Completion Date:||July 2020 (Final data collection date for primary outcome measure)|
Kapetanovic S, Leister E, Nichols S, Miller T, Tassiopoulos K, Hazra R, Gelbard HA, Malee KM, Kammerer B, Mendez AJ, Williams PL; Pediatric HIV/AIDS Cohort Study Team. Relationships between markers of vascular dysfunction and neurodevelopmental outcomes in perinatally HIV-infected youth. AIDS. 2010 Jun 19;24(10):1481-91. doi: 10.1097/QAD.0b013e32833a241b.
Van Dyke RB, Patel K, Siberry GK, Burchett SK, Spector SA, Chernoff MC, Read JS, Mofenson LM, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Antiretroviral treatment of US children with perinatally acquired HIV infection: temporal changes in therapy between 1991 and 2009 and predictors of immunologic and virologic outcomes. J Acquir Immune Defic Syndr. 2011 Jun 1;57(2):165-73. doi: 10.1097/QAI.0b013e318215c7b1.
Siberry GK, Patel K, Van Dyke RB, Hazra R, Burchett SK, Spector SA, Paul ME, Read JS, Wiznia A, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study(PHACS). CD4+ lymphocyte-based immunologic outcomes of perinatally HIV-infected children during antiretroviral therapy interruption. J Acquir Immune Defic Syndr. 2011 Jul 1;57(3):223-9. doi: 10.1097/QAI.0b013e318218e068.
Malee KM, Tassiopoulos K, Huo Y, Siberry G, Williams PL, Hazra R, Smith RA, Allison SM, Garvie PA, Kammerer B, Kapetanovic S, Nichols S, Van Dyke R, Seage GR 3rd, Mellins CA; Pediatric HIV/AIDS Cohort Study Team. Mental health functioning among children and adolescents with perinatal HIV infection and perinatal HIV exposure. AIDS Care. 2011 Dec;23(12):1533-44. doi: 10.1080/09540121.2011.575120.
Mellins CA, Tassiopoulos K, Malee K, Moscicki AB, Patton D, Smith R, Usitalo A, Allison SM, Van Dyke R, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Behavioral health risks in perinatally HIV-exposed youth: co-occurrence of sexual and drug use behavior, mental health problems, and nonadherence to antiretroviral treatment. AIDS Patient Care STDS. 2011 Jul;25(7):413-22. doi: 10.1089/apc.2011.0025. Epub 2011 May 5.
Geffner ME, Patel K, Miller TL, Hazra R, Silio M, Van Dyke RB, Borkowsky W, Worrell C, DiMeglio LA, Jacobson DL; Pediatric HIV/AIDS Cohort Study. Factors associated with insulin resistance among children and adolescents perinatally infected with HIV-1 in the pediatric HIV/AIDS cohort study. Horm Res Paediatr. 2011;76(6):386-91. doi: 10.1159/000332957. Epub 2011 Oct 26.
Jacobson DL, Patel K, Siberry GK, Van Dyke RB, DiMeglio LA, Geffner ME, Chen JS, McFarland EJ, Borkowsky W, Silio M, Fielding RA, Siminski S, Miller TL; Pediatric HIV/AIDS Cohort Study. Body fat distribution in perinatally HIV-infected and HIV-exposed but uninfected children in the era of highly active antiretroviral therapy: outcomes from the Pediatric HIV/AIDS Cohort Study. Am J Clin Nutr. 2011 Dec;94(6):1485-95. doi: 10.3945/ajcn.111.020271. Epub 2011 Nov 2.
Miller TI, Borkowsky W, DiMeglio LA, Dooley L, Geffner ME, Hazra R, McFarland EJ, Mendez AJ, Patel K, Siberry GK, Van Dyke RB, Worrell CJ, Jacobson DL; Pediatric HIV/AIDS Cohort Study (PHACS), Shearer W, Cooper N, Harris L, Purswani M, Baig M, Cintron A, Puga A, Navarro S, Patton D, Burchett S, Karthas N, Kammerer B, Yogev R, Malee K, Hunter S, Cagwin E, Wiznia A, Burey M, Nozyce M, Chen J, Gobs E, Grant M, Knapp K, Allison K, Garvie P, Acevedo-Flores M, Rios H, Olivera V, Silio M, Borne C, Sirois P, Spector S, Norris K, Nichols S, McFarland E, Barr E, Chambers C, Watson D, Messenger N, Belanger R, Dieudonne A, Bettica L, Adubato S, Scott G, Himic L, Willen E. Metabolic abnormalities and viral replication are associated with biomarkers of vascular dysfunction in HIV-infected children. HIV Med. 2012 May;13(5):264-75. doi: 10.1111/j.1468-1293.2011.00970.x. Epub 2011 Dec 4.
Torre P 3rd, Zeldow B, Hoffman HJ, Buchanan A, Siberry GK, Rice M, Sirois PA, Williams PL; Pediatric HIVAIDS Cohort Study. Hearing loss in perinatally HIV-infected and HIV-exposed but uninfected children and adolescents. Pediatr Infect Dis J. 2012 Aug;31(8):835-41. doi: 10.1097/INF.0b013e31825b9524.
Rice ML, Buchanan AL, Siberry GK, Malee KM, Zeldow B, Frederick T, Purswani MU, Hoffman HJ, Sirois PA, Smith R, Torre P 3rd, Allison SM, Williams PL. Language impairment in children perinatally infected with HIV compared to children who were HIV-exposed and uninfected. J Dev Behav Pediatr. 2012 Feb;33(2):112-23. doi: 10.1097/DBP.0b013e318241ed23.
Siberry GK, Leister E, Jacobson DL, Foster SB, Seage GR 3rd, Lipshultz SE, Paul ME, Purswani M, Colin AA, Scott G, Shearer WT. Increased risk of asthma and atopic dermatitis in perinatally HIV-infected children and adolescents. Clin Immunol. 2012 Feb;142(2):201-8. doi: 10.1016/j.clim.2011.10.005. Epub 2011 Oct 30.
Smith R, Chernoff M, Williams PL, Malee KM, Sirois PA, Kammerer B, Wilkins M, Nichols S, Mellins C, Usitalo A, Garvie P, Rutstein R; Pediatric HIV/AIDS Cohort Study (PHACS) Team. Impact of HIV severity on cognitive and adaptive functioning during childhood and adolescence. Pediatr Infect Dis J. 2012 Jun;31(6):592-8. doi: 10.1097/INF.0b013e318253844b.
Tassiopoulos K, Moscicki AB, Mellins C, Kacanek D, Malee K, Allison S, Hazra R, Siberry GK, Smith R, Paul M, Van Dyke RB, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Sexual risk behavior among youth with perinatal HIV infection in the United States: predictors and implications for intervention development. Clin Infect Dis. 2013 Jan;56(2):283-90. doi: 10.1093/cid/cis816. Epub 2012 Nov 7.
DiMeglio LA, Wang J, Siberry GK, Miller TL, Geffner ME, Hazra R, Borkowsky W, Chen JS, Dooley L, Patel K, van Dyke RB, Fielding RA, Gurmu Y, Jacobson DL; Pediatric HIVAIDS Cohort Study (PHACS). Bone mineral density in children and adolescents with perinatal HIV infection. AIDS. 2013 Jan 14;27(2):211-20. doi: 10.1097/QAD.0b013e32835a9b80.
Purswani M, Patel K, Kopp JB, Seage GR 3rd, Chernoff MC, Hazra R, Siberry GK, Mofenson LM, Scott GB, Van Dyke RB; Pediatric HIVAIDS Cohort Study. Tenofovir treatment duration predicts proteinuria in a multiethnic United States Cohort of children and adolescents with perinatal HIV-1 infection. Pediatr Infect Dis J. 2013 May;32(5):495-500. doi: 10.1097/INF.0b013e31827f4eff.
Lipshultz SE, Williams PL, Wilkinson JD, Leister EC, Van Dyke RB, Shearer WT, Rich KC, Hazra R, Kaltman JR, Jacobson DL, Dooley LB, Scott GB, Rabideau N, Colan SD; Pediatric HIV/AIDS Cohort Study (PHACS). Cardiac status of children infected with human immunodeficiency virus who are receiving long-term combination antiretroviral therapy: results from the Adolescent Master Protocol of the Multicenter Pediatric HIV/AIDS Cohort Study. JAMA Pediatr. 2013 Jun;167(6):520-7. doi: 10.1001/jamapediatrics.2013.1206.
Williams PL, Abzug MJ, Jacobson DL, Wang J, Van Dyke RB, Hazra R, Patel K, Dimeglio LA, McFarland EJ, Silio M, Borkowsky W, Seage GR 3rd, Oleske JM, Geffner ME; International Maternal Pediatric and Adolescent AIDS Clinical Trials P219219C Study and the Pediatric HIVAIDS Cohort Study. Pubertal onset in children with perinatal HIV infection in the era of combination antiretroviral treatment. AIDS. 2013 Jul 31;27(12):1959-70. doi: 10.1097/QAD.0b013e328361195b.
Sharma TS, Jacobson DL, Anderson L, Gerschenson M, Van Dyke RB, McFarland EJ, Miller TL; Pediatric HIV/AIDS Cohort Study (PHACS). Short communication: The relationship between mitochondrial dysfunction and insulin resistance in HIV-infected children receiving antiretroviral therapy. AIDS Res Hum Retroviruses. 2013 Sep;29(9):1211-7.
Usitalo A, Leister E, Tassiopoulos K, Allison S, Malee K, Paul ME, Smith R, Van Dyke RB, Seage GR 3rd, Mellins CA. Relationship between viral load and self-report measures of medication adherence among youth with perinatal HIV infection. AIDS Care. 2014 Jan;26(1):107-15. doi: 10.1080/09540121.2013.802280. Epub 2013 Jun 26.
Alperen J, Brummel S, Tassiopoulos K, Mellins CA, Kacanek D, Smith R, Seage GR 3rd, Moscicki AB. Prevalence of and risk factors for substance use among perinatally human immunodeficiency virus-infected and perinatally exposed but uninfected youth. J Adolesc Health. 2014 Mar;54(3):341-9. doi: 10.1016/j.jadohealth.2013.09.003. Epub 2013 Nov 13.
Kapetanovic S, Griner R, Zeldow B, Nichols S, Leister E, Gelbard HA, Miller TL, Hazra R, Mendez AJ, Malee K, Kammerer B, Williams PL; Pediatric HIV/AIDS Cohort Study Team. Biomarkers and neurodevelopment in perinatally HIV-infected or exposed youth: a structural equation model analysis. AIDS. 2014 Jan 28;28(3):355-64. doi: 10.1097/QAD.0000000000000072.
Patel K, Wang J, Jacobson DL, Lipshultz SE, Landy DC, Geffner ME, Dimeglio LA, Seage GR 3rd, Williams PL, Van Dyke RB, Siberry GK, Shearer WT, Young L, Scott GB, Wilkinson JD, Fisher SD, Starc TJ, Miller TL; Pediatric HIV/AIDS Cohort Study (PHACS). Aggregate risk of cardiovascular disease among adolescents perinatally infected with the human immunodeficiency virus. Circulation. 2014 Mar 18;129(11):1204-12. doi: 10.1161/CIRCULATIONAHA.113.001978. Epub 2013 Dec 23.
Siberry GK, Patel K, Pinto JA, Puga A, Mirza A, Miller TL, Van Dyke RB; Pediatric HIVAIDS Cohort Study. Elevated aspartate aminotransferase-to-platelet ratio index in perinatally HIV-infected children in the United States. Pediatr Infect Dis J. 2014 Aug;33(8):855-7. doi: 10.1097/INF.0000000000000348.
Garvie PA, Zeldow B, Malee K, Nichols SL, Smith RA, Wilkins ML, Williams PL; Pediatric HIVAIDS Cohort Study (PHACS). Discordance of cognitive and academic achievement outcomes in youth with perinatal HIV exposure. Pediatr Infect Dis J. 2014 Sep;33(9):e232-8. doi: 10.1097/INF.0000000000000314.
IeDEA and ART Cohort Collaborations, Avila D, Althoff KN, Mugglin C, Wools-Kaloustian K, Koller M, Dabis F, Nash D, Gsponer T, Sungkanuparph S, McGowan C, May M, Cooper D, Chimbetete C, Wolff M, Collier A, McManus H, Davies MA, Costagliola D, Crabtree-Ramirez B, Chaiwarith R, Cescon A, Cornell M, Diero L, Phanuphak P, Sawadogo A, Ehmer J, Eholie SP, Li PC, Fox MP, Gandhi NR, González E, Lee CK, Hoffmann CJ, Kambugu A, Keiser O, Ditangco R, Prozesky H, Lampe F, Kumarasamy N, Kitahata M, Lugina E, Lyamuya R, Vonthanak S, Fink V, d'Arminio Monforte A, Luz PM, Chen YM, Minga A, Casabona J, Mwango A, Choi JY, Newell ML, Bukusi EA, Ngonyani K, Merati TP, Otieno J, Bosco MB, Phiri S, Ng OT, Anastos K, Rockstroh J, Santos I, Oka S, Somi G, Stephan C, Teira R, Wabwire D, Wandeler G, Boulle A, Reiss P, Wood R, Chi BH, Williams C, Sterne JA, Egger M. Immunodeficiency at the start of combination antiretroviral therapy in low-, middle-, and high-income countries. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):e8-16. doi: 10.1097/QAI.0b013e3182a39979.
Persaud D, Patel K, Karalius B, Rainwater-Lovett K, Ziemniak C, Ellis A, Chen YH, Richman D, Siberry GK, Van Dyke RB, Burchett S, Seage GR 3rd, Luzuriaga K; Pediatric HIV/AIDS Cohort Study. Influence of age at virologic control on peripheral blood human immunodeficiency virus reservoir size and serostatus in perinatally infected adolescents. JAMA Pediatr. 2014 Dec;168(12):1138-46. doi: 10.1001/jamapediatrics.2014.1560. Erratum in: JAMA Pediatr. 2015 Jan;169(1):96.
Torre P 3rd, Yao TJ, Zeldow B, Williams P, Hoffman HJ, Siberry GK; Pediatric HIVAIDS Cohort Study (PHACS). Distortion product otoacoustic emission data in perinatally HIV-infected and HIV-exposed but uninfected children and adolescents in the Pediatric HIV/AIDS Cohort Study. Pediatr Infect Dis J. 2015 Mar;34(3):276-8. doi: 10.1097/INF.0000000000000598.
Crowell CS, Huo Y, Tassiopoulos K, Malee KM, Yogev R, Hazra R, Rutstein RM, Nichols SL, Smith RA, Williams PL, Oleske J, Muller WJ; PACTG 219C Study Team and the Pediatric HIVAIDS Cohort Study (PHACS). Early viral suppression improves neurocognitive outcomes in HIV-infected children. AIDS. 2015 Jan 28;29(3):295-304. doi: 10.1097/QAD.0000000000000528.
Krogstad P, Patel K, Karalius B, Hazra R, Abzug MJ, Oleske J, Seage GR 3rd, Williams PL, Borkowsky W, Wiznia A, Pinto J, Van Dyke RB; Pediatric HIVAIDS Cohort Study, IMPAACT 219C, and NICHD International Site Development Initiative (NISDI) Investigators. Incomplete immune reconstitution despite virologic suppression in HIV-1 infected children and adolescents. AIDS. 2015 Mar 27;29(6):683-93. doi: 10.1097/QAD.0000000000000598.
Nichols SL, Brummel SS, Smith RA, Garvie PA, Hunter SJ, Malee KM, Kammerer BL, Wilkins ML, Rutstein R, Tassiopoulos K, Chernoff MC, Mellins CA; Pediatric HIVAIDS Cohort Study. Executive Functioning in Children and Adolescents With Perinatal HIV Infection. Pediatr Infect Dis J. 2015 Sep;34(9):969-75. doi: 10.1097/INF.0000000000000809.
Uban KA, Herting MM, Williams PL, Ajmera T, Gautam P, Huo Y, Malee KM, Yogev R, Csernansky JG, Wang L, Nichols SL, Sowell ER; Pediatric HIVAIDS Cohort and the Pediatric Imaging, Neurocognition, and Genetics Studies. White matter microstructure among youth with perinatally acquired HIV is associated with disease severity. AIDS. 2015 Jun 1;29(9):1035-44. doi: 10.1097/QAD.0000000000000648.
Siberry GK, Patel K, Bellini WJ, Karalius B, Purswani MU, Burchett SK, Meyer WA 3rd, Sowers SB, Ellis A, Van Dyke RB; Pediatric HIV AIDS Cohort Study (PHACS); Pediatric HIV AIDS Cohort Study PHACS. Immunity to Measles, Mumps, and Rubella in US Children With Perinatal HIV Infection or Perinatal HIV Exposure Without Infection. Clin Infect Dis. 2015 Sep 15;61(6):988-95. doi: 10.1093/cid/civ440. Epub 2015 Jun 9.
Herting MM, Uban KA, Williams PL, Gautam P, Huo Y, Malee K, Yogev R, Csernansky J, Wang L, Nichols S, Van Dyke R, Sowell ER. Default Mode Connectivity in Youth With Perinatally Acquired HIV. Medicine (Baltimore). 2015 Sep;94(37):e1417. doi: 10.1097/MD.0000000000001417.
Fairlie L, Karalius B, Patel K, van Dyke RB, Hazra R, Hernán MA, Siberry GK, Seage GR 3rd, Agwu A, Wiznia A; Pediatric HIV AIDS Cohort Study (PHACS), The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT). CD4+ and viral load outcomes of antiretroviral therapy switch strategies after virologic failure of combination antiretroviral therapy in perinatally HIV-infected youth in the United States. AIDS. 2015 Oct 23;29(16):2109-19. doi: 10.1097/QAD.0000000000000809.
Purswani MU, Karalius B, Yao TJ, Schmid DS, Burchett SK, Siberry GK, Patel K, Van Dyke RB, Yogev R; Pediatric HIV/AIDS Cohort Study PHACS. Prevalence and Persistence of Varicella Antibodies in Previously Immunized Children and Youth With Perinatal HIV-1 Infection. Clin Infect Dis. 2016 Jan 1;62(1):106-14. doi: 10.1093/cid/civ734. Epub 2015 Sep 18.
Nichols SL, Chernoff MC, Malee K, Sirois PA, Williams PL, Figueroa V, Woods SP; Memory and Executive Functioning Substudy of the Pediatric HIVAIDS Cohort Study. Learning and Memory in Children and Adolescents With Perinatal HIV Infection and Perinatal HIV Exposure. Pediatr Infect Dis J. 2016 Jun;35(6):649-54. doi: 10.1097/INF.0000000000001131.
Agwu AL, Yao TJ, Eshleman SH, Patel K, Huang W, Burchett SK, Siberry GK, Van Dyke RB; Pediatric HIVAIDS Cohort Study. Phenotypic Coreceptor Tropism in Perinatally HIV-infected Youth Failing Antiretroviral Therapy. Pediatr Infect Dis J. 2016 Jul;35(7):777-81. doi: 10.1097/INF.0000000000001158.
Kapogiannis BG, Leister E, Siberry GK, Van Dyke RB, Rudy B, Flynn P, Williams PL; REACH Study and the PACTG 219219C Study. Prevalence of and progression to abnormal noninvasive markers of liver disease (aspartate aminotransferase-to-platelet ratio index and Fibrosis-4) among US HIV-infected youth. AIDS. 2016 Mar 27;30(6):889-98. doi: 10.1097/QAD.0000000000001003.
Fisher SD, Starc TJ, Guerra V, Williams PL, Wilkinson JD, Lipshultz SE. Declining Incidence of Systolic Left Ventricular Dysfunction in Human Immunodeficiency Virus-Infected Individuals Treated With Highly Active Antiretroviral Therapy. Am J Cardiol. 2016 Apr 1;117(7):1194-5. doi: 10.1016/j.amjcard.2016.01.008. Epub 2016 Jan 14.
Caniglia EC, Patel K, Huo Y, Williams PL, Kapetanovic S, Rich KC, Sirois PA, Jacobson DL, Hernandez-Diaz S, Hernán MA, Seage GR 3rd; Pediatric HIVAIDS Cohort Study. Atazanavir exposure in utero and neurodevelopment in infants: a comparative safety study. AIDS. 2016 May 15;30(8):1267-78. doi: 10.1097/QAD.0000000000001052.
Purswani MU, Patel K, Winkler CA, Spector SA, Hazra R, Seage GR 3rd, Mofenson L, Karalius B, Scott GB, Van Dyke RB, Kopp JB; Pediatric HIVAIDS Cohort Study. APOL1 Renal Risk Variants are Associated with Chronic Kidney Disease in Children and Youth with Perinatal HIV infection. J Acquir Immune Defic Syndr. 2016 Mar 31. [Epub ahead of print]
Van Dyke RB, Patel K, Kagan RM, Karalius B, Traite S, Meyer WA 3rd, Tassiopoulos KK, Seage GR 3rd, Seybolt LM, Burchett S, Hazra R; Pediatric HIV/AIDS Cohort Study (PHACS). Antiretroviral Drug Resistance Among Children and Youth in the United States With Perinatal HIV. Clin Infect Dis. 2016 Jul 1;63(1):133-7. doi: 10.1093/cid/ciw213. Epub 2016 Apr 7.
Van Dyke RB, Chadwick EG, Hazra R, Williams PL, Seage GR 3rd. The PHACS SMARTT Study: Assessment of the Safety of In Utero Exposure to Antiretroviral Drugs. Front Immunol. 2016 May 23;7:199. doi: 10.3389/fimmu.2016.00199. eCollection 2016. Review.
Kacanek D, Malee K, Mellins CA, Tassiopoulos K, Smith R, Grant M, Lee S, Siddiqui DQ, Puga A. Exposure to Violence and Virologic and Immunological Outcomes Among Youth With Perinatal HIV in the Pediatric HIV/AIDS Cohort Study. J Adolesc Health. 2016 Jul;59(1):30-7. doi: 10.1016/j.jadohealth.2016.03.004. Epub 2016 Apr 15.