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Adolescent Master Protocol (AMP)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418014
First Posted: August 16, 2011
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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
  Purpose

The advances in treatment to prevent maternal HIV transmission to neonates have been groundbreaking. As a result, the number of new perinatally-infected children in the U.S. is now small. Subsequent improvements in the treatment of HIV-infected infants and children have been equally remarkable, ensuring that most previously infected American children have survived and are approaching adolescence. In addition, the number of HIV-infected adolescents worldwide is growing substantially in both resource-poor countries and in countries with increasing levels of health care. Therefore, there is a global cohort of children who have been living with HIV infection since birth who are aging into adolescence. Little is definitively known about the impact of HIV infection and its treatment on the maturation process in these children.

AMP is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy on pre-adolescents and adolescents with perinatal HIV infection. Domains to be investigated include growth and sexual maturation, metabolic risk factors for cardiovascular disease, cardiac function, bone health, neurologic, neurodevelopment, language, hearing and behavioral function, and sexually transmitted infections (STI).


Condition
HIV/AIDS

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adolescent Master Protocol

Resource links provided by NLM:


Further study details as provided by George Seage, Harvard School of Public Health:

Primary Outcome Measures:
  • Abnormal growth [ Time Frame: Annually for 10 years ]
    Assessed via measurement of height, weight, skinfold thickness, mid-upper arm and waist and hip circumference, nutrition and physical activity questionnaires ; subjects meeting growth trigger based on height measurements also have the following laboratory assessments: IGF-I, IGFBP-3, and GHBP. A growth hormone stimulation test may also be required at the recommendation of the endocrinologist.

  • Delayed sexual maturation [ Time Frame: Annually for 10 years except if subject reaches Tanner Stage 5 ]
    Assessed via tanner staging; subjects meeting the growth trigger based on the results of the tanner staging will also have the following laboratory assessments: morning LH, FSH, estradiol, and testosterone

  • Abnormal bone mineral density [ Time Frame: Two DXAs, two years apart, per HIV-infected subject; one DXA per uninfected subject; X-ray at same time as DXA unless subject Tanner Stage 5 ]
    Assessed via DXA scan and x-ray for bone age; subjects meeting the BMD trigger based on the DXA also have the following laboratory assessments: TSH, calcium, 25-hydroxy-vitamin D, bone-specific alkaline, N-terminal telopeptide of type I collagen phosphatase, and PTH in real time and repository specimens for assay of pro-inflammatory cytokines (IL-1, IL-6, TNF-a)

  • Dyslipidemia [ Time Frame: Annually for 10 years ]
    Assessed via lipid testing; subjects meeting the metabolic trigger based on the results of the lipid tests also have the following measurements: endothelial dysfunction (I, E, P-selectins: V, I-CAM-1, endothelin-1, hs-CRP, homocysteine, apolipoprotein B, lipoprotein (a), and vWF antigen)

  • Cardiac abnormalities [ Time Frame: Measured once per subject until study reached 400 echocardiograms ]
    Assessed through the administration of echocardiograms and serum biomarkers (ProBNP)

  • Hearing dysfunction [ Time Frame: Once per subject. ]
    Assessed via audiologic evaluation conducted by an audiologist.

  • Language dysfunction [ Time Frame: Annually for 10 years ]
    Assessed using the Woodcock and CELF IV language tests

  • Neurodevelopmental abnormalities [ Time Frame: Annually for 10 years ]
    Assessed via the following neurodevelopmental tests: WISC IV, WAIS IV, BRIEF, Children's Color Trails Test, Trail Making Tests, WIAT-II screen, ABAS, Parent Child Relationship Inventory, BASC-2, Quality of Life Interview, Stressful Life Events Questionnaire, Monitoring the Future

  • Substance Use [ Time Frame: Annually starting at a minimum of 10 years of age for 10 years ]
    The assessment of sexual activity is conducted using an Audio Computer Assisted Survey Instrument (ACASI). ACASI uses computer and voice recordings so that the participant hears (through headphones) and sees (on the screen) each question and response list. The use of ACASI is proven to minimize response bias due to the presence of an interviewer.

  • Sexual Activity [ Time Frame: Annually starting at a minimum of 10 years of age for 10 years ]
    The assessment of substance use is conducted using an Audio Computer Assisted Survey Instrument (ACASI). ACASI uses computer and voice recordings so that the participant hears (through headphones) and sees (on the screen) each question and response list. The use of ACASI is proven to minimize response bias due to the presence of an interviewer.

  • Pregnancy [ Time Frame: Annually for 10 years ]
    Assessed via medical record review to record incidents of pregnancy

  • Sexually Transmitted Infection [ Time Frame: Annually for 10 years ]
    Assessed via medical record review to record results of clinically conducted STI and Pap testing and pelvic exams

  • Mitochondrial dysfunction [ Time Frame: Annually for 10 years ]
    Assessed via measurement of serum lactate levels, OXPHO immunoassays, mitochondrial specific oxidative stress, mtDNA copies/cell, mrRNA transcripts

  • Lactic acidosis [ Time Frame: Annually for 10 years ]
    Assessed through the measurement of blood lactate levels using a point-of-care lactate measuring device; a single venous lactate measurement will be conducted in cases where the POC lactate measure is elevated

  • Renal abnormalities [ Time Frame: Annually for 10 years ]
    Assessed through the following laboratory measurements: chemistry panel, urinalysis, protein/creatinine ratio, dip stick urine test


Biospecimen Retention:   Samples With DNA
Serum, cell pellets, plasma, saliva, and urine

Enrollment: 678
Study Start Date: March 2007
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Infected Cohort
Perinatally HIV-infected adolescents from 7 years of age (7th birthday) up to but not including the 16th birthday at enrollment, engaged in care with ART treatment history available.
Uninfected Cohort
HIV-uninfected adolescents from 7 years of age (7th birthday) up to but not including the 16th birthday at enrollment born to HIV-infected mothers.

Detailed Description:

The primary objectives of AMP are:

  1. To define the impact of HIV infection and ART on growth and pubertal development (and their hormonal regulation), along with the cognitive, academic, and social development, of pre-adolescents and adolescents with perinatal HIV infection as they move through adolescence into adulthood.
  2. To identify infectious and non-infectious complications of HIV disease, including the toxicities of antiretroviral therapy (ART).
  3. To investigate:

    • Cognitive and behavioral changes over time, including medication adherence, family and social function, and high risk behaviors such as risky sexual behavior, licit and illicit drug use, and alcohol use;
    • Changes in language and hearing;
    • Changes in glucose metabolism, body composition, and bone mineralization;
    • Changes in lipid metabolism and other risk factors for cardiovascular disease;
    • Risk factors for secondary transmission of HIV; and
    • The occurrence and clinical course of cervical HPV infections among females.

The domain-specific aims of AMP are:

  1. Growth and sexual maturation: To longitudinally track growth and sexual maturation and the factors that influence growth and maturation in HIV-infected children when compared to HIV-exposed but uninfected children.
  2. Metabolic risk factors for cardiovascular disease: To characterize the emergence of abnormal glucose metabolism, lipid abnormalities, body composition and other risk factors for cardiovascular disease and identify the contributing influences in HIV-infected children when compared to HIV-exposed but uninfected children.
  3. Cardiac function: To estimate the prevalence of cardiac structural and functional abnormalities in HIV-infected children and youth when compared to HIV-exposed but uninfected children.
  4. Bone mineral density: To estimate the differences in bone mineral density of HIV-infected children when compared to HIV-exposed but uninfected children and to identify factors contributing to abnormal bone mineralization.
  5. Neurologic, neurodevelopment, language, and behavioral function:

    • To examine cognitive and behavioral outcomes of HIV-infected children and adolescents, including high risk behaviors such as risky sexual behavior, licit and illicit drug use, and alcohol use, neurodevelopmental impairment, school achievement and to compare them with an HIV-exposed but uninfected control cohort.
    • To examine non-adherence to antiretroviral therapy and predictors of non-adherence among HIV-infected children receiving ART.
    • To examine family and psychosocial factors associated with emotional and behavioral problems.
  6. Adolescent gynecology and STI infection:

    • To evaluate the incidence of and risk factors for acquiring STIs/vaginal infections (C. trachomatis, N. gonorrhea, T. vaginalis, syphilis, genital warts, HPV, and HSV) for males and females, and in addition bacterial vaginosis for females.
    • To evaluate the incidence, predictors, and outcomes of pregnancy.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected and -uninfected children from 7 years of age (7th birthday) up to but not including the 16th birthday at the time of enrollment born to HIV-infected mothers. Participants will be children previously enrolled in any of the studies included on the list of approved studies for co-enrollment into AMP noted above, or another study with Protocol Team approval or has medical record documentation since birth of key medical data related to their HIV infection.
Criteria

HIV-Infected Cohort

Inclusion Criteria:

  • Perinatal HIV infection as documented in the medical record.
  • Age 7 years (7th birthday) up to but not including the 16th birthday at enrollment.
  • Engaged in care and ART history is available.
  • Either: Previous or current enrollment in any of the studies included on the list of approved studies allowing for enrollment into AMP. Children participating in other studies may be enrolled with approval of the Protocol Team. Additional approved protocols will be listed on the PHACS website; Or: Available medical record documentation since birth of 1)ART exposure history 2)Opportunistic Infection (OI) prophylaxis exposure history 3) Viral load and CD4 count history and 4) Major medical events history
  • Willingness to participate and provide parental/legal guardian permission with assent. Children who do not know their HIV infection status will not be excluded.

Exclusion criteria: HIV acquired by other than maternal-child transmission (e.g., blood products, sexual contact, and IV drug use) as documented in the medical record.

HIV-Uninfected, HIV-Exposed Control Cohort

Inclusion criteria:

  • HIV-uninfected and born to an HIV-infected mother as documented in the medical record.
  • Age 7 years (7th birthday) up to but not including the 16th birthday at enrollment.
  • Previous or current enrollment in any of the studies included on the list of approved studies allowing for enrollment into AMP. Children participating in other studies may be enrolled with approval of the Protocol Team. Additional approved protocols will be listed on the PHACS website; Or: Available medical record documentation since birth of 1)ART exposure history and 2) Major medical events history.
  • Willingness to participate and provide parental/legal guardian permission with assent.

Exclusion Criteria: None.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418014


Locations
United States, California
University of California San Diego
La Jolla, California, United States, 92093
United States, Colorado
University of Colorado Denver Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Florida
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States, 33316
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, United States, 60614
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, New Jersey
Rutgers - New Jersey Medical School
Newark, New Jersey, United States, 07101
United States, New York
Bronx Lebanon Hospital Center
The Bronx, New York, United States, 10457
Jacobi Medical Center
The Bronx, New York, United States, 10461
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Puerto Rico
San Juan Research Hospital
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
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)
Investigators
Principal Investigator: George R Seage III, ScD, MPH Harvard School of Public Health
Principal Investigator: Russell Van Dyke, M.D. Tulane University School of Medicine
  More Information

Additional Information:
Publications:
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), Lurie RH, Yogev R, Sanders MA, Malee K, Hunter S, Shearer W, Paul M, Cooper N, Harris L, Purswani M, Baig M, Cintron A, Puga A, Navarro S, Garvie P, Blood J, Burchett S, Karthas N, Kammerer B, Wiznia A, Burey M, Nozyce M, Dieudonne A, Bettica L, Adubato S, Chen J, Bulkley MG, Ivey L, Grant M, Knapp K, Allison K, Wilkins M, Acevedo-Flores M, Rios H, Olivera V, Silio M, Jones M, Sirois P, Spector S, Norris K, Nichols S, McFarland E, Katai A, Dunn J, Paul S, Scott G, Bryan P, Willen E. 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):106-114. 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. Brief Report: APOL1 Renal Risk Variants Are Associated With Chronic Kidney Disease in Children and Youth With Perinatal HIV Infection. J Acquir Immune Defic Syndr. 2016 Sep 1;73(1):63-8. doi: 10.1097/QAI.0000000000001010.
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), Lurie RH, Yogev R, Sanders MA, Malee K, Hunter S, Shearer W, Paul M, Cooper N, Harris L, Purswani M, Baig M, Cintron A, Puga A, Navarro S, Garvie P, Blood J, Burchett S, Karthas N, Kammerer B, Wiznia A, Burey M, Nozyce M, Dieudonne A, Bettica L, Adubato S, Chen J, Bulkley MG, Ivey L, Grant M, Knapp K, Allison K, Wilkins M, Acevedo-Flores M, Rios H, Olivera V, Silio M, Jones M, Sirois P, Spector S, Norris K, Nichols S, McFarland E, Katai A, Dunn J, Paul S, Scott G, Bryan P, Willen E. Antiretroviral Drug Resistance Among Children and Youth in the United States With Perinatal HIV. Clin Infect Dis. 2016 Jul 1;63(1):133-137. 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.
Moscicki AB, Yao TJ, Ryder MI, Russell JS, Dominy SS, Patel K, McKenna M, Van Dyke RB, Seage GR 3rd, Hazra R; Shiboski. The Burden of Oral Disease among Perinatally HIV-Infected and HIV-Exposed Uninfected Youth. PLoS One. 2016 Jun 14;11(6):e0156459. doi: 10.1371/journal.pone.0156459. eCollection 2016.
Spector SA, Brummel SS, Nievergelt CM, Maihofer AX, Singh KK, Purswani MU, Williams PL, Hazra R, Van Dyke R, Seage GR 3rd; Pediatric HIVAIDS Cohort Study (PHACS). Genetically determined ancestry is more informative than self-reported race in HIV-infected and -exposed children. Medicine (Baltimore). 2016 Sep;95(36):e4733. doi: 10.1097/MD.0000000000004733.
Lewis-de Los Angeles CP, Alpert KI, Williams PL, Malee K, Huo Y, Csernansky JG, Yogev R, Van Dyke RB, Sowell ER, Wang L; Pediatric HIV/AIDS Cohort Study (PHACS). Deformed Subcortical Structures Are Related to Past HIV Disease Severity in Youth With Perinatally Acquired HIV Infection. J Pediatric Infect Dis Soc. 2016 Dec;5(suppl 1):S6-S14.
Sirois PA, Chernoff MC, Malee KM, Garvie PA, Harris LL, Williams PL, Woods SP, Nozyce ML, Kammerer BL, Yildirim C, Nichols SL; Memory and Executive Functioning Study of the Pediatric HIV/AIDS Cohort Study. Associations of Memory and Executive Functioning With Academic and Adaptive Functioning Among Youth With Perinatal HIV Exposure and/or Infection. J Pediatric Infect Dis Soc. 2016 Dec;5(suppl 1):S24-S32.
Takemoto JK, Miller TL, Wang J, Jacobson DL, Geffner ME, Van Dyke RB, Gerschenson M; Pediatric HIVAIDS Cohort Study. Insulin resistance in HIV-infected youth is associated with decreased mitochondrial respiration. AIDS. 2017 Jan 2;31(1):15-23.
Uprety P, Patel K, Karalius B, Ziemniak C, Chen YH, Brummel SS, Siminski S, Van Dyke RB, Seage GR, Persaud D; Pediatric HIV/AIDS Cohort Study (PHACS) . Human Immunodeficiency Virus Type 1 DNA Decay Dynamics With Early, Long-term Virologic Control of Perinatal Infection. Clin Infect Dis. 2017 Jun 1;64(11):1471-1478. doi: 10.1093/cid/cix192.
Lewis-de Los Angeles CP, Williams PL, Huo Y, Wang SD, Uban KA, Herting MM, Malee K, Yogev R, Csernansky JG, Nichols S, Van Dyke RB, Sowell ER, Wang L; Pediatric HIV/AIDS Cohort Study (PHACS) and the Pediatric Imaging, Neurocognition, and Genetics (PING) Study. Lower total and regional grey matter brain volumes in youth with perinatally-acquired HIV infection: Associations with HIV disease severity, substance use, and cognition. Brain Behav Immun. 2017 May;62:100-109. doi: 10.1016/j.bbi.2017.01.004. Epub 2017 Jan 10.
Neilan AM, Karalius B, Patel K, Van Dyke RB, Abzug MJ, Agwu AL, Williams PL, Purswani M, Kacanek D, Oleske JM, Burchett SK, Wiznia A, Chernoff M, Seage GR 3rd, Ciaranello AL; Pediatric HIV/AIDS Cohort Study and the International Maternal Adolescent and Pediatric AIDS Clinical Trials Network. Association of Risk of Viremia, Immunosuppression, Serious Clinical Events, and Mortality With Increasing Age in Perinatally Human Immunodeficiency Virus-Infected Youth. JAMA Pediatr. 2017 May 1;171(5):450-460. doi: 10.1001/jamapediatrics.2017.0141.
Shearer WT, Jacobson DL, Yu W, Siberry GK, Purswani M, Siminski S, Butler L, Leister E, Scott G, Van Dyke RB, Yogev R, Paul ME, Puga A, Colin AA, Kattan M; Pediatric HIV/AIDS Cohort Study. Long-term pulmonary complications in perinatally HIV-infected youth. J Allergy Clin Immunol. 2017 Mar 6. pii: S0091-6749(17)30336-6. doi: 10.1016/j.jaci.2017.01.031. [Epub ahead of print]
Bellavia A, Williams PL, DiMeglio LA, Hazra R, Abzug MJ, Patel K, Jacobson DL, Van Dyke RB, Geffner ME; International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P219/219C Study, and the Pediatric HIV/AIDS Cohort Study (PHACS). Delay in sexual maturation in perinatally HIV-infected youths is mediated by poor growth. AIDS. 2017 Jun 1;31(9):1333-1341. doi: 10.1097/QAD.0000000000001486.
Jacobson DL, Stephensen CB, Miller TL, Patel K, Chen JS, Van Dyke RB, Mirza A, Schuster GU, Hazra R, Ellis A, Brummel SS, Geffner ME, Silio M, Spector SA, DiMeglio LA; Pediatric HIV/AIDS Cohort Study. Associations of Low Vitamin D and Elevated Parathyroid Hormone Concentrations With Bone Mineral Density in Perinatally HIV-Infected Children. J Acquir Immune Defic Syndr. 2017 Sep 1;76(1):33-42. doi: 10.1097/QAI.0000000000001467.
Garvie PA, Brummel SS, Allison SM, Malee KM, Mellins CA, Wilkins ML, Harris LL, Patton ED, Chernoff MC, Rutstein RM, Paul ME, Nichols SL; Pediatric HIV/AIDS Cohort Study. Roles of Medication Responsibility, Executive and Adaptive Functioning in Adherence for Children and Adolescents With Perinatally Acquired HIV. Pediatr Infect Dis J. 2017 Aug;36(8):751-757. doi: 10.1097/INF.0000000000001573.

Responsible Party: George Seage, Professor of Epidemiology, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01418014     History of Changes
Other Study ID Numbers: HD052102 - PH200
PH200 ( Other Identifier: PHACS Protocol Number )
First Submitted: July 22, 2011
First Posted: August 16, 2011
Last Update Posted: August 24, 2017
Last Verified: August 2017


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