Adolescent Master Protocol

HIV/AIDS Clinical Trial

— AMP  

Official title:

Adolescent Master Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418014
• Other study ID #: HD052102 - PH200
• Secondary ID: PH200
• Status: Completed
• Start date: March 2007
• Est. completion date: February 2021

Study information

• Verified date: November 2023
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 678
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

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 as specified in the protocol. Children participating in other studies may be enrolled with approval of the Protocol Team. Additional approved protocols are 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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Locations

Country	Name	City	State
Puerto Rico	San Juan Research Hospital	San Juan
United States	University of Colorado Denver Health Sciences Center	Aurora	Colorado
United States	University of Maryland	Baltimore	Maryland
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Bronx Lebanon Hospital Center	Bronx	New York
United States	Jacobi Medical Center	Bronx	New York
United States	Ann and Robert H. Lurie Children's Hospital	Chicago	Illinois
United States	Children's Diagnostic and Treatment Center	Fort Lauderdale	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	University of California San Diego	La Jolla	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Rutgers - New Jersey Medical School	Newark	New Jersey
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania

Sponsors (12)

Lead Sponsor

Collaborator

Harvard School of Public Health (HSPH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Drug Abuse (NIDA), NIH Office of AIDS Research (OAR), Tulane University School of Medicine

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (106)

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- — View Citation

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 Adole — View Citation

Alperen J, Davidson J, Siminski S, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Utility of the National Death Index in Identifying Deaths in a Clinic-Based, Multisite Cohort: The Experience of the Pediatric HIV/AIDS Cohort Study. J Acquir Immune Defic S — View Citation

Attia EF, Jacobson D, Yu W, Crowell CS, Maleche-Obimbo E, Williams PL, West TE, Burchett SK, Kattan M, Colin AA, Eskander S, Chung MH, Crothers K, Shearer WT; Pediatric HIV/AIDS Cohort Study. Immune imbalance and activation are associated with lower lung — View Citation

Barnard-Mayers R, Kouser H, Cohen JA, Tassiopoulos K, Caniglia EC, Moscicki AB, Campos NG, Caunca MR, Seage GRS, Murray EJ. A case study and proposal for publishing directed acyclic graphs: The effectiveness of the quadrivalent human papillomavirus vaccin — View Citation

Bather JR, Williams PL, Broadwell C, Smith R, Patel K, Garvie PA, Karalius B, Kacanek D, Mellins CA, Malee K; Pediatric HIV/AIDS Cohort Study (PHACS). Racial/Ethnic Disparities in Longitudinal Emotional-Behavioral Functioning Among Youth Born to Women Liv — View Citation

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 s — View Citation

Berman CA, Kacanek D, Nichamin M, Wilson D, Davtyan M, Salomon L, Patel K, Reznick M, Tassiopoulos K, Lee S, Bauermeister J, Paul M, Aldape T, Seage Iii GR. Using Social Media and Technology to Communicate in Pediatric HIV Research: Qualitative Study With — View Citation

Brummel SS, Van Dyke RB, Patel K, Purswani M, Seage GR, Yao TJ, Hazra R, Karalius B, Williams PL; Pediatric HIV/AIDS Cohort Study. Analyzing Longitudinally Collected Viral Load Measurements in Youth With Perinatally Acquired HIV Infection: Problems and Po — View Citation

Caniglia EC, Patel K, Huo Y, Williams PL, Kapetanovic S, Rich KC, Sirois PA, Jacobson DL, Hernandez-Diaz S, Hernan MA, Seage GR 3rd; Pediatric HIVAIDS Cohort Study. Atazanavir exposure in utero and neurodevelopment in infants: a comparative safety study. — View Citation

Collaborative Initiative for Paediatric HIV Education and Research (CIPHER) Global Cohort Collaboration. Incidence of switching to second-line antiretroviral therapy and associated factors in children with HIV: an international cohort collaboration. Lance — View Citation

Collaborative Initiative for Paediatric HIV Education and Research (CIPHER) Global Cohort Collaboration; Jesson J, Crichton S, Quartagno M, Yotebieng M, Abrams EJ, Chokephaibulkit K, Le Coeur S, Ake-Assi MH, Patel K, Pinto J, Paul M, Vreeman R, Davies MA, — View Citation

Collaborative Initiative for Paediatric HIV Education and Research (CIPHER) Global Cohort Collaboration; Slogrove AL, Schomaker M, Davies MA, Williams P, Balkan S, Ben-Farhat J, Calles N, Chokephaibulkit K, Duff C, Eboua TF, Kekitiinwa-Rukyalekere A, Maxw — View Citation

Correia K, Williams PL. A hierarchical modeling approach for assessing the safety of exposure to complex antiretroviral drug regimens during pregnancy. Stat Methods Med Res. 2019 Feb;28(2):599-612. doi: 10.1177/0962280217732597. Epub 2017 Oct 3. — View Citation

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 outco — View Citation

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 perinat — View Citation

Dirajlal-Fargo S, Jacobson DL, Yu W, Mirza A, Geffner ME, Jao J, McComsey GA. Gut Dysfunction Markers Are Associated With Body Composition in Youth Living With Perinatally Acquired Human Immunodeficiency Virus. Clin Infect Dis. 2022 Sep 29;75(6):945-952. — View Citation

Dirajlal-Fargo S, Williams PL, Broadwell C, McFarland EJ, Powis KM, Jacobson DL, Jao J; Pediatric HIV/AIDS Cohort Study (PHACS). Brief Report: Youth Living With Perinatally Acquired HIV Have Lower Physical Activity Levels as They Age Compared With HIV-Exp — View Citation

Fairlie L, Karalius B, Patel K, van Dyke RB, Hazra R, Hernan 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 outco — View Citation

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 — View Citation

Fulcher IR, Tchetgen Tchetgen EJ, Williams PL. Mediation Analysis for Censored Survival Data Under an Accelerated Failure Time Model. Epidemiology. 2017 Sep;28(5):660-666. doi: 10.1097/EDE.0000000000000687. — View Citation

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 — View Citation

Garvie PA, Nichols SL, Williams PL, Harris LL, Kammerer B, Chernoff MC, Figueroa V, Woods SP. Development and reliability of the Prospective Memory Assessment for Children & Youth (PROMACY): A preliminary study in a nonclinical sample. Appl Neuropsychol C — View Citation

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 — View Citation

Geffner ME, Patel K, Jacobson DL, Wu J, Miller TL, Hazra R, Gerschenson M, Sharma T, Silio M, Jao J, Takemoto JK, Van Dyke RB, DiMeglio LA; Pediatric HIV/AIDS Cohort Study (PHACS). Changes in insulin sensitivity over time and associated factors in HIV-inf — View Citation

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 — View Citation

Gojanovich GS, Jacobson DL, Jao J, Russell JS, Van Dyke RB, Libutti DE, Sharma TS, Geffner ME, Gerschenson M. Mitochondrial Dysfunction and Insulin Resistance in Pubertal Youth Living with Perinatally Acquired HIV. AIDS Res Hum Retroviruses. 2020 Sep;36(9 — View Citation

Harris LL, Chernoff MC, Nichols SL, Williams PL, Garvie PA, Yildirim C, McCauley SR, Woods SP; Memory and Executive Functioning Study of the Pediatric HIV/AIDS Cohort Study. Prospective memory in youth with perinatally-acquired HIV infection. Child Neurop — View Citation

Hermetet-Lindsay KD, Correia KF, Williams PL, Smith R, Malee KM, Mellins CA, Rutstein RM; Pediatric HIV/AIDS Cohort Study. Contributions of Disease Severity, Psychosocial Factors, and Cognition to Behavioral Functioning in US Youth Perinatally Exposed to — View Citation

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.000 — View Citation

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-Ram — View Citation

Innes S, Patel K. Noncommunicable diseases in adolescents with perinatally acquired HIV-1 infection in high-income and low-income settings. Curr Opin HIV AIDS. 2018 May;13(3):187-195. doi: 10.1097/COH.0000000000000458. — View Citation

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 — View Citation

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 — View Citation

Jacobson DL, Yu W, Hazra R, Brummel S, Geffner ME, Patel K, Borkowsky W, Wang J, Chen JS, Mirza A, DiMeglio LA; Pediatric HIV/AIDS Cohort Study. Fractures in children and adolescents living with perinatally acquired HIV. Bone. 2020 Oct;139:115515. doi: 10 — View Citation

Jao J, Jacobson DL, Russell JS, Wang J, Yu W, Gojanovich GS, Siminski S, Hyzy L, Geffner ME, Gerschenson M; for the Pediatric HIV/AIDS Cohort Study. Perinatally acquired HIV infection is associated with abnormal blood mitochondrial function during childho — View Citation

Jao J, Yu W, Patel K, Miller TL, Karalius B, Geffner ME, DiMeglio LA, Mirza A, Chen JS, Silio M, McFarland EJ, Van Dyke RB, Jacobson D; Pediatric HIV/AIDS Cohort Study (PHACS) Adolescent Master Protocol (AMP) study. Improvement in lipids after switch to b — View Citation

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;5 — View Citation

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 str — View Citation

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 i — View Citation

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 a — View Citation

Koller M, Patel K, Chi BH, Wools-Kaloustian K, Dicko F, Chokephaibulkit K, Chimbetete C, Avila D, Hazra R, Ayaya S, Leroy V, Truong HK, Egger M, Davies MA; IeDEA, NISDI, PHACS and IMPAACT 219C studies. Immunodeficiency in children starting antiretroviral — View Citation

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. — View Citation

Lee KH, Coull BA, Moscicki AB, Paster BJ, Starr JR. Bayesian variable selection for multivariate zero-inflated models: Application to microbiome count data. Biostatistics. 2020 Jul 1;21(3):499-517. doi: 10.1093/biostatistics/kxy067. — View Citation

Lemon TL, Tassiopoulos K, Tsai AC, Cantos K, Escudero D, Quinn MK, Kacanek D, Berman C, Salomon L, Nichols S, Chadwick EG, Seage GR 3rd, Williams PL; Pediatric HIV/AIDS Cohort Study (PHACS). Health Insurance Coverage, Clinical Outcomes, and Health-Related Quality of Life Among Youth Born to Women Living With HIV. J Acquir Immune Defic Syndr. 2023 Jan 1;92(1):6-16. doi: 10.1097/QAI.0000000000003100. — View Citation

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 Perina — View Citation

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) S — View Citation

Lewis-de Los Angeles CP, Williams PL, Jenkins LM, Huo Y, Malee K, Alpert KI, Uban KA, Herting MM, Csernansky JG, Nichols SL, Van Dyke RB, Sowell ER, Wang L; Pediatric HIV/AIDS Cohort Study (PHACS) and the Pediatric Imaging, Neurocognition, and Genetics (P — View Citation

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 imm — View Citation

Malee KM, Chernoff MC, Sirois PA, Williams PL, Garvie PA, Kammerer BL, Harris LL, Nozyce ML, Yildirim C, Nichols SL; Memory and Executive Functioning Study of the Pediatric HIV/AIDS Cohort Study. Impact of Perinatally Acquired HIV Disease Upon Longitudina — View Citation

Malee KM, Smith RA, Mellins CA; Pediatric HIV/AIDS Cohort Study. Brain and Cognitive Development Among U.S. Youth With Perinatally Acquired Human Immunodeficiency Virus Infection. J Pediatric Infect Dis Soc. 2016 Dec;5(suppl 1):S1-S5. doi: 10.1093/jpids/p — View Citation

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 a — View Citation

Margossian R, Williams PL, Yu W, Jacobson DL, Geffner ME, DiMeglio LA, Van Dyke RB, Spector SA, Schuster GU, Stephensen CB, Miller TL, Lipshultz SE; Pediatric HIV/AIDS Cohort Study (PHACS). Markers of Bone Mineral Metabolism and Cardiac Structure and Func — View Citation

McManus M, Karalius B, Patel K, Persaud D, Luzuriaga K; Pediatric HIV/AIDS Cohort Study. Quantitative HIV-1-specific antibodies as predictors of peripheral blood cell-associated HIV-1 DNA concentrations. AIDS. 2020 Jul 1;34(8):1117-1126. doi: 10.1097/QAD. — View Citation

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, — View Citation

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, — View Citation

Moscicki AB, Farhat S, Yao TJ, Ryder MI, Russell JS, Van Dyke RB, Hazra R, Shiboski CH; Pediatric HIVAIDS Cohort Study. Oral Human Papillomavirus in Youth From the Pediatric HIV/AIDS Cohort Study. Sex Transm Dis. 2016 Aug;43(8):498-500. doi: 10.1097/OLQ.0 — View Citation

Moscicki AB, Karalius B, Tassiopoulos K, Yao TJ, Jacobson DL, Patel K, Purswani M, Seage GR; Pediatric HIV/AIDS Cohort Study. Human Papillomavirus Antibody Levels and Quadrivalent Vaccine Clinical Effectiveness in Perinatally Human Immunodeficiency Virus- — View Citation

Moscicki AB, Yao TJ, Russell JS, Farhat S, Scott M, Magpantay L, Halec G, Shiboski CH, Ryder MI; Pediatric HIV/AIDS Cohort Study. Biomarkers of oral inflammation in perinatally HIV-infected and perinatally HIV-exposed, uninfected youth. J Clin Periodontol — View Citation

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: — View Citation

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 Pe — View Citation

Nichols SL, Brummel S, Malee KM, Mellins CA, Moscicki AB, Smith R, Cuadra AM, Bryant K, Boyce CA, Tassiopoulos KK; Pediatric HIV/AIDS Cohort Study. The Role of Behavioral and Neurocognitive Functioning in Substance Use Among Youth with Perinatally Acquire — View Citation

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. — View Citation

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 — View Citation

Nichols SL, Chernoff MC, Malee KM, Sirois PA, Woods SP, Williams PL, Yildirim C, Delis D, Kammerer B; Memory and Executive Functioning Study of the Pediatric HIV/AIDS Cohort Study. Executive Functioning in Children and Adolescents With Perinatal HIV Infec — View Citation

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). Aggreg — View Citation

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 i — View Citation

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 adole — View Citation

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, Cintr — View Citation

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 — View Citation

Rawat P, Brummel SS, Singh KK, Kim J, Frazer KA, Nichols S, Seage GR, Williams PL, Van Dyke RB, Harismendy O, Trout RN, Spector SA. Genomics Links Inflammation With Neurocognitive Impairment in Children Living With Human Immunodeficiency Virus Type-1. J I — View Citation

Redmond SM, Yao TJ, Russell JS, Rice ML, Hoffman HJ, Siberry GK, Frederick T, Purswani M, Williams PL; Pediatric HIV/AIDS Cohort Study. Longitudinal Evaluation of Language Impairment in Youth With Perinatally Acquired Human Immunodeficiency Virus (HIV) an — View Citation

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 a — View Citation

Ryder MI, Shiboski C, Yao TJ, Moscicki AB. Current trends and new developments in HIV research and periodontal diseases. Periodontol 2000. 2020 Feb;82(1):65-77. doi: 10.1111/prd.12321. — View Citation

Ryder MI, Yao TJ, Russell JS, Moscicki AB, Shiboski CH; Pediatric HIV/AIDS Cohort Study. Prevalence of periodontal diseases in a multicenter cohort of perinatally HIV-infected and HIV-exposed and uninfected youth. J Clin Periodontol. 2017 Jan;44(1):2-12. — View Citation

Schulte F, King OD, Paster BJ, Moscicki AB, Yao TJ, Van Dyke RB, Shiboski C, Ryder M, Seage G, Hardt M; Pediatric HIV/AIDS Cohort Study. Salivary metabolite levels in perinatally HIV-infected youth with periodontal disease. Metabolomics. 2020 Sep 11;16(9) — View Citation

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 recei — View Citation

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 yout — View Citation

Shiau S, Brummel SS, Kennedy EM, Hermetz K, Spector SA, Williams PL, Kacanek D, Smith R, Drury SS, Agwu A, Ellis A, Patel K, Seage GR 3rd, Van Dyke RB, Marsit CJ; Pediatric HIV/AIDS Cohort Study (PHACS). Longitudinal changes in epigenetic age in youth wit — View Citation

Shiau S, Yu W, Jacobson DL, Nichols S, McFarland EJ, Chen JS, Dirajlal-Fargo S, Surowiec K, Geffner ME, Jao J; Pediatric HIV/AIDS Cohort Study. Components of metabolic syndrome associated with lower neurocognitive performance in youth with perinatally acq — View Citation

Shiboski CH, Yao TJ, Russell JS, Ryder MI, Van Dyke RB, Seage GR 3rd, Moscicki AB; Pediatric HIV/AIDS Cohort Study. The association between oral disease and type of antiretroviral therapy among perinatally HIV-infected youth. AIDS. 2018 Nov 13;32(17):2497 — View Citation

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( — View Citation

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 Wi — View Citation

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;3 — View Citation

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 the — View Citation

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 — View Citation

Sirois PA, Huo Y, Nozyce ML, Garvie PA, Harris LL, Malee K, McEvoy R, Mellins CA, Nichols SL, Smith R, Tassiopoulos K; Pediatric HIV/AIDS Cohort Study. Ageing with HIV: a longitudinal study of markers of resilience in young adults with perinatal exposure to HIV, with or without perinatally acquired HIV. J Int AIDS Soc. 2022 Sep;25 Suppl 4(Suppl 4):e25982. doi: 10.1002/jia2.25982. — View Citation

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 childhoo — View Citation

Smith R, Huo Y, Tassiopoulos K, Rutstein R, Kapetanovic S, Mellins C, Kacanek D, Malee K; Pediatric HIV/AIDS Cohort Study (PHACS). Mental Health Diagnoses, Symptoms, and Service Utilization in US Youth with Perinatal HIV Infection or HIV Exposure. AIDS Pa — View Citation

Spector SA, Brummel SS, Nievergelt CM, Maihofer AX, Singh KK, Purswani MU, Williams PL, Hazra R, Van Dyke R, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study (PHACS). Genetically determined ancestry is more informative than self-reported race in HIV-infected — View Citation

Starr JR, Huang Y, Lee KH, Murphy CM, Moscicki AB, Shiboski CH, Ryder MI, Yao TJ, Faller LL, Van Dyke RB, Paster BJ; Pediatric HIV/AIDS Cohort Study. Oral microbiota in youth with perinatally acquired HIV infection. Microbiome. 2018 May 31;6(1):100. doi: — View Citation

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. doi: 10.109 — View Citation

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: pr — View Citation

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 HI — View Citation

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( — View Citation

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 — View Citation

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 Perina — View Citation

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 J — View Citation

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. — View Citation

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, Har — View Citation

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 betwe — View Citation

Wilkinson JD, Williams PL, Yu W, Colan SD, Mendez A, Zachariah JPV, Van Dyke RB, Shearer WT, Margossian RE, Lipshultz SE; Pediatric HIV/AIDS Cohort Study (PHACS). Cardiac and inflammatory biomarkers in perinatally HIV-infected and HIV-exposed uninfected c — View Citation

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 Pe — View Citation

Williams PL, Correia K, Karalius B, Van Dyke RB, Wilkinson JD, Shearer WT, Colan SD, Lipshultz SE; Pediatric HIV/AIDS Cohort Study. Cardiac status of perinatally HIV-infected children: assessing combination antiretroviral regimens in observational studies — View Citation

Williams PL, Jesson J. Growth and pubertal development in HIV-infected adolescents. Curr Opin HIV AIDS. 2018 May;13(3):179-186. doi: 10.1097/COH.0000000000000450. — View Citation

Yildirim C, Garvie PA, Chernoff M, Wilkins ML, Patton ED, Williams PL, Nichols SL; Memory and Executive Functioning Study of the Pediatric HIV/AIDS Cohort Study. The Role of Pharmacy Refill Measures in Assessing Adherence and Predicting HIV Disease Marker — View Citation

* Note: There are 106 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal growth	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.	Annually for 10 years
Primary	Delayed sexual maturation	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	Annually for 10 years except if subject reaches Tanner Stage 5
Primary	Abnormal bone mineral density	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)	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
Primary	Dyslipidemia	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)	Annually for 10 years
Primary	Cardiac abnormalities	Assessed through the administration of echocardiograms and serum biomarkers (ProBNP)	Measured once per subject until study reached 400 echocardiograms
Primary	Hearing dysfunction	Assessed via audiologic evaluation conducted by an audiologist.	Once per subject.
Primary	Language dysfunction	Assessed using the Woodcock and CELF IV language tests	Annually for 10 years
Primary	Neurodevelopmental abnormalities	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	Annually for 10 years
Primary	Substance Use	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.	Annually starting at a minimum of 10 years of age for 10 years
Primary	Sexual Activity	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.	Annually starting at a minimum of 10 years of age for 10 years
Primary	Pregnancy	Assessed via medical record review to record incidents of pregnancy	Annually for 10 years
Primary	Sexually Transmitted Infection	Assessed via medical record review to record results of clinically conducted STI and Pap testing and pelvic exams	Annually for 10 years
Primary	Mitochondrial dysfunction	Assessed via measurement of serum lactate levels, OXPHO immunoassays, mitochondrial specific oxidative stress, mtDNA copies/cell, mrRNA transcripts	Annually for 10 years
Primary	Lactic acidosis	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	Annually for 10 years
Primary	Renal abnormalities	Assessed through the following laboratory measurements: chemistry panel, urinalysis, protein/creatinine ratio, dip stick urine test	Annually for 10 years

External Links

•   Pediatric HIV/AIDS Cohort Study