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Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women (SMARTT)

This study is currently recruiting participants.
Verified August 2017 by George Seage, Harvard School of Public Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310023
First Posted: March 7, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. 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
SMARTT will estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born of HIV-infected mothers.

Condition
Antiretroviral Toxicity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Lactic acidosis [ Time Frame: Birth, 1, 3, 5, 7, 9, 11, 13, 15, and 17 years of age. ]
    Assessed through the measurement of blood lactate levels using a point-of-care lactate measuring device. Venous lactate and pyruvate levels will be measured for children for whom the point-of-care lactate measurement is abnormal.

  • Neurologic abnormalities [ Time Frame: Annually birth through age 5; semiannual thereafter, assessments vary based on age of child. ]
    Assessed via head circumference measurement and medical record review for documented clinical diagnoses of seizures, microcephaly, or other neurologic diagnosis.

  • Neurodevelopmental abnormalities [ Time Frame: 1, 3, 5, 9, and 13 years of age, assessments vary based on age of child. ]
    Assessed via the following neurodevelopmental tests: Bayley Screener, Bayley III, WPPSI-III, BASC-2, WASI, WISC-IV, BRIEF, WIAT II.

  • Abnormal growth and metabolic function [ Time Frame: Annually birth through age 5; semiannual thereafter, assessments vary based on age of child. ]
    Assessed through the measurement of height, weight, tricep skinfold thickness, mid-upperarm circumference measurements, insulin and glucose, and fasting lipids.

  • Cardiac abnormalities [ Time Frame: Ages 3-5. ]
    Assessed through the administration of echocardiograms and serum biomarkers (ProBNP).

  • Hearing dysfunction [ Time Frame: At age 5 and for children of all ages meeting a hearing/language trigger. ]
    Assessed via audiologic evaluation conducted by an audiologist.

  • Language dysfunction [ Time Frame: 1, 2, 3, 5, and 9 years of age, assessments vary based on age. ]
    Assessed via the following language tests: MCDI, Ages and Stages Communication Scale, PPVT IV, Goldman Fristoe 2, Rice Wexler, TELD-3, TOLD-3, Woodcock, CELF IV.

  • Drug Use and Sexual Activity [ Time Frame: 11, 13, 15, and 17 years of age. ]
    The assessment of sexual behavior and substance use will be 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.

  • Abnormal organ function [ Time Frame: Birth and age one, semiannual thereafter. ]
    Assessed through the measurement of lipase, CPK, ALT, creatinine, glucose, LDH, BUN, WBC, PMN, lymphocytes, platelets, or hemoglobin ( ≥ Grade 3 adverse event).

  • Death due to unknown medical condition [ Time Frame: Annual. ]
    Assessed through autopsy review.


Secondary Outcome Measures:
  • Maternal substance use during pregnancy [ Time Frame: Entry visit. ]
    Obtained via interview, toxicology report, and meconium testing.


Biospecimen Retention:   Samples With DNA
Serum, cell pellets, meconium, saliva, hair

Estimated Enrollment: 3400
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
Static Cohort
HIV-uninfected children < 12 years of age at the time of enrollment, born of HIV-infected mothers
Dynamic Cohort
HIV-uninfected children born of HIV-infected mothers enrolled from prior to birth through ≤ 72 hours of age
Reference Cohort
HIV-uninfected children born to a mother HIV uninfected at the time of the child's birth enrolled at 1, 3, 5, or 9 years of age(± 3 months) at the time of the study visit
Young Adult Cohort
Former Dynamic and Static Cohort participants ≥ 18 years of age.

Detailed Description:

Many antiretroviral therapy (ART) medications given to a pregnant woman cross the placenta and can be detected in the amniotic fluid and cord blood resulting in substantial fetal exposure. Therefore, there is concern about toxicity of the drugs in the fetus and infant. It is noteworthy that none of the currently approved ART medications for the prevention of maternal to fetal transmission of HIV are in Food and Drug Administration (FDA) Pregnancy Category A (no fetal risk ascertained in adequately controlled human studies). Thus, there is continued need to examine the toxicity of ART in HIV transmission prevention for the short-term toxicity of newer agents and combinations as well as the unanswered questions of longer term toxicity and subtle adverse effects.

The study will use a registry approach to conduct active surveillance among children < 12 years of age at enrollment. Occurrences of abnormalities from ART exposure in utero and/or in the first two months of life will be sought in multiple domains, including metabolic, growth, cardiac, neurologic, neurodevelopmental, behavior, language, and hearing. Clinical and laboratory data will be examined for abnormalities through a hierarchy of evaluations: adverse events (AE) will be identified → selected AEs will trigger predefined additional evaluations → significant observations will be defined as cases → a pattern of significant study-wide cases will be defined as signals. The incidence of these events of interest will be monitored over time and by ART regimen, and compared with historical data that may be suggestive of a signal. Some signals may be testable using existing and/or previously collected data, while other signals may indicate the need for additional hypothesis-driven studies outside of SMARTT.

The objectives of SMARTT are:

  1. To estimate the occurrence of potential ART-related toxicities through an ongoing surveillance system among HIV-uninfected children born to mothers with HIV infection with and without exposure to ART in utero and/or in the first two months of life and compare the occurrences of these outcomes with other sources of data as well as by ART exposures; and
  2. To actively encourage hypothesis-driven studies to confirm that the signals are due to ART exposure in utero and/or in the first two months of life. Note that the full design and execution of these studies may be beyond the scope of the SMARTT study but will be facilitated by SMARTT.

The specific aims of SMARTT are:

  1. To create a Static Surveillance Cohort to extend domain-specific data collection in children either 1) previously enrolled in any of the approved studies for enrollment into SMARTT; 2) previously enrolled in another pediatric HIV/AIDS cohort study with SMARTT Protocol Chair approval, or 3) not previously enrolled in an approved study but with equivalent data available in the medical record;
  2. To create a Dynamic Surveillance Cohort to examine domain-specific data of children newly exposed to ART in utero and/or in the first two months of life;
  3. To create a Young Adult Cohort to study long-term outcomes in SMARTT participants formerly enrolled in the Static and Dynamic cohorts.
  4. To identify a set of "triggers" for each domain that define a "signal" of possible ART toxicity and compare the occurrence of these signals with previously collected data and by ART exposure; and
  5. To encourage and facilitate the development of hypothesis-driven studies to evaluate whether a "signal" is the result of ART exposure in utero and/or in the first two months of life.
  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:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children aged 0 - < 12 years born of HIV-infected mothers recruited from a clinical setting.
Criteria

Inclusion Criteria:

Static Surveillance Cohort:

  • HIV-exposed but -uninfected infants and children; lack of infection must be documented by medical or research record review. Children exposed and unexposed to ART while in utero and/or in the first two months of life will be enrolled.
  • Previously enrolled in any of the studies included on the list of approved studies for enrollment into SMARTT or another study with SMARTT Protocol Chair approval if the study has data on ART exposure by pregnancy trimester, ART exposure during the first 2 months of life, and pregnancy complication data or availability of ART exposure by pregnancy trimester (including start and stop dates), ART exposure during the first 2 months of life, and pregnancy complication data in the mother and/or child's medical record.
  • Age birth to < 12 years at entry.
  • Willingness of parent/legal guardian to provide written permission for child to participate in study.

Dynamic Surveillance Cohort:

  • HIV-exposed living fetus greater than or equal to 23 weeks gestation or a live infant born after 22 weeks gestation. Infants exposed and unexposed to ART will be enrolled.
  • Any infant born of an HIV-infected mother may be enrolled pending determination of the infant's HIV infection status. However, infants found to be HIV-positive will be discontinued from the study and will be referred for care outside this study. HIV infection status will be determined using the Diagnosis of Lack of Infection in HIV-Exposed Children.
  • ART exposure data by trimester of pregnancy must be available if ART exposed.
  • Entry prior to birth through < 72 hours of age.
  • Willingness of parent/legal guardian to provide written permission for child to participate in study.
  • Willingness of biological mother to enroll at initial enrollment of her child.

Young Adult Cohort:

  • 18 years of age or older, and aware of their perinatal HIV exposure status.
  • Previously enrolled in the SMARTT Dynamic or Static Cohort.
  • Willingness to provide written consent to participate in the study.

Reference Cohort:

  • Participants from clinical settings that are similar to participants enrolled in the PHACS SMARTT Static Cohort.
  • Antiretroviral therapy unexposed children born to a mother HIV uninfected at the time of the child's birth.
  • Ages 1, 3, 5, or 9 years (± 3 months) at the time of the study visit.
  • Willingness of parent/legal guardian to provide written permission for child to participate in study.

Exclusion Criteria:

Static and Dynamic Cohorts:

Young Adult Cohort:

  • Participants enrolled in the Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up).
  • Current prisoner status.

Reference Cohort:

  • Monolingual Spanish-speaking child or parent/caregiver.
  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): NCT01310023


Contacts
Contact: Julie K Alperen, DrPH 617-432-6762 jalperen@hsph.harvard.edu
Contact: Lauren E Nisotel, BS 617-432-0146 lnisotel@hsph.harvard.edu

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Marilyn Crain, MD         
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Principal Investigator: Stephen Spector, MD         
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Toinette Frederick, PhD         
United States, Colorado
University of Colorado Denver Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Elizabeth McFarland, MD         
United States, Florida
Children's Diagnostic & Treatment Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Principal Investigator: Ana Puga, MD         
University of Florida Health Science Center Recruiting
Jacksonville, Florida, United States, 32209
Principal Investigator: Mobeen Rathore, MD         
University of Miami Recruiting
Miami, Florida, United States, 33136
Principal Investigator: Gwendolyn Scott, MD         
United States, Illinois
University of Illinois, Chicago Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Karen Hayani, MD         
Ann and Robert H. Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60614
Principal Investigator: Ram Yogev, MD         
United States, Louisiana
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Principal Investigator: Russell Van Dyke, MD         
United States, Maryland
University of Maryland Terminated
Baltimore, Maryland, United States, 21201
United States, New Jersey
Rutgers - New Jersey Medical School Recruiting
Newark, New Jersey, United States, 07101-1709
Principal Investigator: Arry Dieudonne, MD         
United States, New York
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203-2098
Principal Investigator: Hermann Mendez, MD         
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Principal Investigator: William Borkowsky, MD         
SUNY Stony Brook Terminated
Stony Brook, New York, United States, 11794
Bronx Lebanon Hospital Center Recruiting
The Bronx, New York, United States, 10457
Principal Investigator: Murli Purswani, MD         
Jacobi Medical Center Terminated
The Bronx, New York, United States, 10461
United States, Pennsylvania
Children's Hospital of Philadelphia Terminated
Philadelphia, Pennsylvania, United States, 19104-4318
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105-2764
Principal Investigator: Katherine Knapp, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030-3498
Principal Investigator: Wililam Shearer, MD, PhD         
Puerto Rico
University of Puerto Rico Medical Center Recruiting
San Juan, Puerto Rico, 00935
Principal Investigator: Zoe Rodriguez, MD         
San Juan Research Hospital Recruiting
San Juan, Puerto Rico, 00936-8344
Principal Investigator: Nicolas Rosario-Matos, MD         
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, ScD, MPH Harvard School of Public Health
Principal Investigator: Russell Van Dyke, M.D. Tulane University School of Medicine
  More Information

Additional Information:
Publications:
Tassiopoulos K, Read JS, Brogly S, Rich K, Lester B, Spector SA, Yogev R, Seage GR 3rd. Substance use in HIV-Infected women during pregnancy: self-report versus meconium analysis. AIDS Behav. 2010 Dec;14(6):1269-78. doi: 10.1007/s10461-010-9705-0.
Griner R, Williams PL, Read JS, Seage GR 3rd, Crain M, Yogev R, Hazra R, Rich K; Pediatric HIV/AIDS Cohort Study. In utero and postnatal exposure to antiretrovirals among HIV-exposed but uninfected children in the United States. AIDS Patient Care STDS. 2011 Jul;25(7):385-94. doi: 10.1089/apc.2011.0068. Epub 2011 Jun 10.
Crain MJ, Williams PL, Griner R, Tassiopoulos K, Read JS, Mofenson LM, Rich KC; Pediatric HIVAIDS Cohort Study. Point-of-care capillary blood lactate measurements in human immunodeficiency virus-uninfected children with in utero exposure to human immunodeficiency virus and antiretroviral medications. Pediatr Infect Dis J. 2011 Dec;30(12):1069-74. doi: 10.1097/INF.0b013e318234c886.
Williams PL, Seage GR 3rd, Van Dyke RB, Siberry GK, Griner R, Tassiopoulos K, Yildirim C, Read JS, Huo Y, Hazra R, Jacobson DL, Mofenson LM, Rich K; Pediatric HIV/AIDS Cohort Study. A trigger-based design for evaluating the safety of in utero antiretroviral exposure in uninfected children of human immunodeficiency virus-infected mothers. Am J Epidemiol. 2012 May 1;175(9):950-61. doi: 10.1093/aje/kwr401. Epub 2012 Apr 6.
Siberry GK, Williams PL, Mendez H, Seage GR 3rd, Jacobson DL, Hazra R, Rich KC, Griner R, Tassiopoulos K, Kacanek D, Mofenson LM, Miller T, DiMeglio LA, Watts DH; Pediatric HIV/AIDS Cohort Study (PHACS). Safety of tenofovir use during pregnancy: early growth outcomes in HIV-exposed uninfected infants. AIDS. 2012 Jun 1;26(9):1151-9. doi: 10.1097/QAD.0b013e328352d135.
Watts DH, Williams PL, Kacanek D, Griner R, Rich K, Hazra R, Mofenson LM, Mendez HA; Pediatric HIV/AIDS Cohort Study. Combination antiretroviral use and preterm birth. J Infect Dis. 2013 Feb 15;207(4):612-21. doi: 10.1093/infdis/jis728. Epub 2012 Nov 29.
Wilkinson JD, Williams PL, Leister E, Zeldow B, Shearer WT, Colan SD, Siberry GK, Dooley LB, Scott GB, Rich KC, Lipshultz SE; Pediatric HIVAIDS Cohort Study (PHACS). Cardiac biomarkers in HIV-exposed uninfected children. AIDS. 2013 Apr 24;27(7):1099-108. doi: 10.1097/QAD.0b013e32835cf21c.
Sirois PA, Huo Y, Williams PL, Malee K, Garvie PA, Kammerer B, Rich K, Van Dyke RB, Nozyce ML; Pediatric HIVAIDS Cohort Study. Safety of perinatal exposure to antiretroviral medications: developmental outcomes in infants. Pediatr Infect Dis J. 2013 Jun;32(6):648-55. doi: 10.1097/INF.0b013e318284129a.
Himes SK, Scheidweiler KB, Tassiopoulos K, Kacanek D, Hazra R, Rich K, Huestis MA; Pediatric HIV/AIDS Cohort Study. Development and validation of the first liquid chromatography-tandem mass spectrometry assay for simultaneous quantification of multiple antiretrovirals in meconium. Anal Chem. 2013 Feb 5;85(3):1896-904. doi: 10.1021/ac303188j. Epub 2013 Jan 14.
Rice ML, Zeldow B, Siberry GK, Purswani M, Malee K, Hoffman HJ, Frederick T, Buchanan A, Sirois PA, Allison SM, Williams PL; Pediatric HIVAIDS Cohort Study (PHACS). Evaluation of risk for late language emergence after in utero antiretroviral drug exposure in HIV-exposed uninfected infants. Pediatr Infect Dis J. 2013 Oct;32(10):e406-13. doi: 10.1097/INF.0b013e31829b80ee.
Malee KM, Mellins CA, Huo Y, Tassiopoulos K, Smith R, Sirois PA, Allison SM, Kacanek D, Kapetanovic S, Williams PL, Grant ML, Marullo D, Aidala AA; Pediatric HIVAIDS Cohort Study (PHACS). Prevalence, incidence, and persistence of psychiatric and substance use disorders among mothers living with HIV. J Acquir Immune Defic Syndr. 2014 Apr 15;65(5):526-34. doi: 10.1097/QAI.0000000000000070.
Nozyce ML, Huo Y, Williams PL, Kapetanovic S, Hazra R, Nichols S, Hunter S, Smith R, Seage GR 3rd, Sirois PA; Pediatric HIVAIDS Cohort Study. Safety of in utero and neonatal antiretroviral exposure: cognitive and academic outcomes in HIV-exposed, uninfected children 5-13 years of age. Pediatr Infect Dis J. 2014 Nov;33(11):1128-33. doi: 10.1097/INF.0000000000000410.
Williams PL, Crain MJ, Yildirim C, Hazra R, Van Dyke RB, Rich K, Read JS, Stuard E, Rathore M, Mendez HA, Watts DH; Pediatric HIV/AIDS Cohort Study. Congenital anomalies and in utero antiretroviral exposure in human immunodeficiency virus-exposed uninfected infants. JAMA Pediatr. 2015 Jan;169(1):48-55. doi: 10.1001/jamapediatrics.2014.1889.
Lipshultz SE, Williams PL, Zeldow B, Wilkinson JD, Rich KC, van Dyke RB, Seage GR 3rd, Dooley LB, Kaltman JR, Siberry GK, Mofenson LM, Shearer WT, Colan SD; Pediatric HIVAIDS Cohort Study (PHACS). Cardiac effects of in-utero exposure to antiretroviral therapy in HIV-uninfected children born to HIV-infected mothers. AIDS. 2015 Jan 2;29(1):91-100. doi: 10.1097/QAD.0000000000000499.
Rough K, Tassiopoulos K, Kacanek D, Griner R, Yogev R, Rich KC, Seage GR 3rd; Pediatric HIVAIDS Cohort Study. Dramatic decline in substance use by HIV-infected pregnant women in the United States from 1990 to 2012. AIDS. 2015 Jan 2;29(1):117-23. doi: 10.1097/QAD.0000000000000503.
Himes SK, Wu JW, Jacobson DL, Tassiopoulos K, Hazra R, Kacanek D, Van Dyke RB, Rich KC, Siberry GK, Huestis MA; Pediatric HIVAIDS Cohort Study (PHACS). Meconium Tenofovir Concentrations and Growth and Bone Outcomes in Prenatally Tenofovir Exposed HIV-Uninfected Children. Pediatr Infect Dis J. 2015 Aug;34(8):851-7. doi: 10.1097/INF.0000000000000747.
Himes SK, Huo Y, Siberry GK, Williams PL, Rice ML, Sirois PA, Frederick T, Hazra R, Huestis MA; Pediatric HIVAIDS Cohort Study. Meconium Atazanavir Concentrations and Early Language Outcomes in HIV-Exposed Uninfected Infants With Prenatal Atazanavir Exposure. J Acquir Immune Defic Syndr. 2015 Jun 1;69(2):178-86. doi: 10.1097/QAI.0000000000000558.
Himes SK, Tassiopoulos K, Yogev R, Huestis MA; Pediatric HIV/AIDS Cohort Study (PHACS). Antiretroviral Drugs in Meconium: Detection for Different Gestational Periods of Exposure. J Pediatr. 2015 Aug;167(2):305-11.e3. doi: 10.1016/j.jpeds.2015.04.062. Epub 2015 May 19.
Marsit CJ, Brummel SS, Kacanek D, Seage GR 3rd, Spector SA, Armstrong DA, Lester BM, Rich K; Pediatric HIV/AIDS Cohort Studies Network. Infant peripheral blood repetitive element hypomethylation associated with antiretroviral therapy in utero. Epigenetics. 2015;10(8):708-16. doi: 10.1080/15592294.2015.1060389.
Siberry GK, Jacobson DL, Kalkwarf HJ, Wu JW, DiMeglio LA, Yogev R, Knapp KM, Wheeler JJ, Butler L, Hazra R, Miller TL, Seage GR 3rd, Van Dyke RB, Barr E, Davtyan M, Mofenson LM, Rich KC; Pediatric HIV/AIDS Cohort Study. Lower Newborn Bone Mineral Content Associated With Maternal Use of Tenofovir Disoproxil Fumarate During Pregnancy. Clin Infect Dis. 2015 Sep 15;61(6):996-1003. doi: 10.1093/cid/civ437. Epub 2015 Jun 9.
Williams PL, Hazra R, Van Dyke RB, Yildirim C, Crain MJ, Seage GR 3rd, Civitello L, Ellis A, Butler L, Rich K; Pediatric HIV/AIDS Cohort Study. Antiretroviral exposure during pregnancy and adverse outcomes in HIV-exposed uninfected infants and children using a trigger-based design. AIDS. 2016 Jan 2;30(1):133-44. doi: 10.1097/QAD.0000000000000916.
Kirmse B, Yao TJ, Hofherr S, Kacanek D, Williams PL, Hobbs CV, Hazra R, Borkowsky W, Van Dyke RB, Summar M. Acylcarnitine Profiles in HIV-Exposed, Uninfected Neonates in the United States. AIDS Res Hum Retroviruses. 2016 Apr;32(4):339-48. doi: 10.1089/AID.2015.0112. Epub 2016 Jan 19.
Guerra V, Leister EC, Williams PL, Starc TJ, Lipshultz SE, Wilkinson JD, Van Dyke RB, Hazra R, Colan SD. Long-Term Effects of In Utero Antiretroviral Exposure: Systolic and Diastolic Function in HIV-Exposed Uninfected Youth. AIDS Res Hum Retroviruses. 2016 Jul;32(7):621-7. doi: 10.1089/AID.2015.0281. Epub 2016 May 9.
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.
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.
Jacobson DL, Patel K, Williams PL, Geffner ME, Siberry GK, DiMeglio LA, Crain MJ, Mirza A, Chen JS, McFarland E, Kacanek D, Silio M, Rich K, Borkowsky W, Van Dyke RB, Miller TL; Pediatric HIVAIDS Cohort Study. Growth at 2 Years of Age in HIV-exposed Uninfected Children in the United States by Trimester of Maternal Antiretroviral Initiation. Pediatr Infect Dis J. 2017 Feb;36(2):189-197. doi: 10.1097/INF.0000000000001387.
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 HIV. AIDS Behav. 2016 Jul 30. [Epub ahead of print] Erratum in: AIDS Behav. 2016 Aug 27;:.
Zash RM, Williams PL, Sibiude J, Lyall H, Kakkar F. Surveillance monitoring for safety of in utero antiretroviral therapy exposures: current strategies and challenges. Expert Opin Drug Saf. 2016 Nov;15(11):1501-1513. Epub 2016 Sep 6. Review.
Torre P Rd, Zeldow B, Yao TJ, Hoffman HJ, Siberry GK, Purswani MU, Frederick T, Spector SA, Williams PL. Newborn Hearing Screenings in Human Immunodeficiency Virus-Exposed Uninfected Infants. J AIDS Immune Res. 2016;1(1). pii: 102. Epub 2016 Sep 5.
Tassiopoulos K, Huo Y, Braun J, Williams PL, Smith R, Aschengrau A, Nichols S, Hazra R, Meyer WA, Knapp K, Deygoo NS, Seage Iii GR. Blood lead levels and neurodevelopmental function in perinatally HIV-exposed, uninfected children in a US-based longitudinal cohort study. AIDS Res Hum Retroviruses. 2017 Mar 21. doi: 10.1089/AID.2016.0265. [Epub ahead of print]

Responsible Party: George Seage, Professor of Epidemiology, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01310023     History of Changes
Obsolete Identifiers: NCT00647803
Other Study ID Numbers: HD052102 - PH100
PH100 ( Other Identifier: PHACS Protocol Number )
First Submitted: March 4, 2011
First Posted: March 7, 2011
Last Update Posted: August 24, 2017
Last Verified: August 2017

Keywords provided by George Seage, Harvard School of Public Health:
Conditions and diagnoses potentially related to perinatal exposure to antiretroviral medications


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