Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women
NCT ID: NCT01310023
Last Updated: 2025-06-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
5169 participants
Study Classification
OBSERVATIONAL
Study Start Date
2007-03-31
Study Completion Date
2025-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
NCT00000750
HIV Infections
COMPLETED
PHASE3
Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
NCT01061151
HIV Infections
COMPLETED
PHASE3
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
NCT02140255
HIV Infection
RECRUITING
PHASE1/PHASE2
Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
NCT00028145
HIV Infections
Pregnancy Complications, Infectious
COMPLETED
Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women
NCT03227731
HIV-1-infection
COMPLETED
PHASE2/PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Antiretroviral Toxicity
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Static Cohort- closed to enrollment and follow-up
HIV-uninfected children \< 12 years of age at the time of enrollment, born of HIV-infected mothers
No interventions assigned to this group
Dynamic Cohort
HIV-uninfected children born of HIV-infected mothers enrolled from prior to birth through ≤ 72 hours of age
No interventions assigned to this group
Reference Cohort- closed to enrollment and follow-up
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
No interventions assigned to this group
Young Adult Cohort- closed to enrollment and follow-up
Former Dynamic and Static Cohort participants ≥ 18 years of age.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Dynamic 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.
* 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.
Exclusion Criteria
Dynamic Cohort:
None
None
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
collaborator
National Institute on Drug Abuse (NIDA)
NIH
Sponsor Role
collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Sponsor Role
collaborator
National Institute of Mental Health (NIMH)
NIH
Sponsor Role
collaborator
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
Sponsor Role
collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Sponsor Role
collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Sponsor Role
collaborator
Tulane University School of Medicine
OTHER
Sponsor Role
collaborator
National Institute of Dental and Craniofacial Research (NIDCR)
NIH
Sponsor Role
collaborator
NIH Office of AIDS Research (OAR)
NIH
Sponsor Role
collaborator
Harvard School of Public Health (HSPH)
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Paige Williams
Senior Lecturer on Biostatistics
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paige L Williams
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Ellen Chadwick, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama
Birmingham, Alabama, United States
Site Status
University of California San Diego
La Jolla, California, United States
Site Status
University of Southern California
Los Angeles, California, United States
Site Status
University of Colorado Denver Health Sciences Center
Aurora, Colorado, United States
Site Status
Children's Diagnostic & Treatment Center
Fort Lauderdale, Florida, United States
Site Status
University of Florida Health Science Center
Jacksonville, Florida, United States
Site Status
University of Miami
Miami, Florida, United States
Site Status
University of Illinois, Chicago
Chicago, Illinois, United States
Site Status
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, United States
Site Status
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Site Status
University of Maryland
Baltimore, Maryland, United States
Site Status
Rutgers - New Jersey Medical School
Newark, New Jersey, United States
Site Status
SUNY Downstate Medical Center
Brooklyn, New York, United States
Site Status
New York University School of Medicine
New York, New York, United States
Site Status
SUNY Stony Brook
Stony Brook, New York, United States
Site Status
Bronx Lebanon Hospital Center
The Bronx, New York, United States
Site Status
Jacobi Medical Center
The Bronx, New York, United States
Site Status
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Site Status
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Site Status
Baylor College of Medicine
Houston, Texas, United States
Site Status
University of Puerto Rico Medical Center
San Juan, PR, Puerto Rico
Site Status
San Juan Research Hospital
San Juan, , Puerto Rico
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Puerto Rico
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
Correia K, Williams PL. Estimating the Relative Excess Risk Due to Interaction in Clustered-Data Settings. Am J Epidemiol. 2018 Nov 1;187(11):2470-2480. doi: 10.1093/aje/kwy154.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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. doi: 10.1080/14740338.2016.1226281. Epub 2016 Sep 6.
Reference Type
BACKGROUND
Bather JR, Horton NJ, Coull BA, Williams PL. The impact of correlated exposures and missing data on multiple informant models used to identify critical exposure windows. Stat Med. 2023 Apr 15;42(8):1171-1187. doi: 10.1002/sim.9664. Epub 2023 Jan 16.
Reference Type
BACKGROUND
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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. AIDS. 2016 May 15;30(8):1267-78. doi: 10.1097/QAD.0000000000001052.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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. 2017 Sep;21(9):2703-2715. doi: 10.1007/s10461-016-1508-5.
Reference Type
RESULT
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 Sep;33(9):919-928. doi: 10.1089/AID.2016.0265. Epub 2017 Mar 21.
Reference Type
RESULT
Jao J, Kacanek D, Williams PL, Geffner ME, Livingston EG, Sperling RS, Patel K, Bardeguez AD, Burchett SK, Chakhtoura N, Scott GB, Van Dyke RB, Abrams EJ; Pediatric HIV/AIDS Cohort Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials P1025 Protocol; Pediatric HIV/AIDS Cohort Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials P1025 Protocol. Birth Weight and Preterm Delivery Outcomes of Perinatally vs Nonperinatally Human Immunodeficiency Virus-Infected Pregnant Women in the United States: Results From the PHACS SMARTT Study and IMPAACT P1025 Protocol. Clin Infect Dis. 2017 Sep 15;65(6):982-989. doi: 10.1093/cid/cix488.
Reference Type
RESULT
Rough K, Seage GR 3rd, Williams PL, Hernandez-Diaz S, Huo Y, Chadwick EG, Currier JS, Hoffman RM, Barr E, Shapiro DE, Patel K; PHACS and the IMPAACT P1025 Study Teams. Birth Outcomes for Pregnant Women with HIV Using Tenofovir-Emtricitabine. N Engl J Med. 2018 Apr 26;378(17):1593-1603. doi: 10.1056/NEJMoa1701666.
Reference Type
RESULT
Goodenough CJ, Patel K, Van Dyke RB; Pediatric HIV/AIDS Cohort Study (PHACS). Is There a Higher Risk of Mother-to-child Transmission of HIV Among Pregnant Women With Perinatal HIV Infection? Pediatr Infect Dis J. 2018 Dec;37(12):1267-1270. doi: 10.1097/INF.0000000000002084.
Reference Type
RESULT
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 Syndr. 2018 Sep 1;79(1):e37-e39. doi: 10.1097/QAI.0000000000001763. No abstract available.
Reference Type
RESULT
Jao J, Jacobson DL, Yu W, Borkowsky W, Geffner ME, McFarland EJ, Patel K, Williams PL, Miller T; Pediatric HIV/AIDS Cohort Study. A Comparison of Metabolic Outcomes Between Obese HIV-Exposed Uninfected Youth From the PHACS SMARTT Study and HIV-Unexposed Youth From the NHANES Study in the United States. J Acquir Immune Defic Syndr. 2019 Jul 1;81(3):319-327. doi: 10.1097/QAI.0000000000002018.
Reference Type
RESULT
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 Function in Perinatally HIV-Infected and HIV-Exposed but Uninfected Children and Adolescents. J Acquir Immune Defic Syndr. 2019 Jun 1;81(2):238-246. doi: 10.1097/QAI.0000000000002007.
Reference Type
RESULT
Sudfeld CR, Jacobson DL, Rueda NM, Neri D, Mendez AJ, Butler L, Siminski S, Hendricks KM, Mellins CA, Duggan CP, Miller TL; Pediatric HIV/AIDS Cohort Study. Third Trimester Vitamin D Status Is Associated With Birth Outcomes and Linear Growth of HIV-Exposed Uninfected Infants in the United States. J Acquir Immune Defic Syndr. 2019 Jul 1;81(3):336-344. doi: 10.1097/QAI.0000000000002041.
Reference Type
RESULT
Wang Y, Brummel SS, Beilstein-Wedel E, Dagnall CL, Hazra R, Kacanek D, Chadwick EG, Marsit CJ, Chanock SJ, Savage SA, Poirier MC, Machiela MJ, Engels EA; Pediatric HIV/AIDS Cohort Study. Association between zidovudine-containing antiretroviral therapy exposure in utero and leukocyte telomere length at birth. AIDS. 2019 Nov 1;33(13):2091-2096. doi: 10.1097/QAD.0000000000002317.
Reference Type
RESULT
Purswani MU, Russell JS, Dietrich M, Malee K, Spector SA, Williams PL, Frederick T, Burchett S, Redmond S, Hoffman HJ, Torre P 3rd, Lee S, Rice ML, Yao TJ; Pediatric HIV/AIDS Cohort Study. Birth Prevalence of Congenital Cytomegalovirus Infection in HIV-Exposed Uninfected Children in the Era of Combination Antiretroviral Therapy. J Pediatr. 2020 Jan;216:82-87.e2. doi: 10.1016/j.jpeds.2019.09.025. Epub 2019 Oct 23.
Reference Type
RESULT
Williams PL, Yildirim C, Chadwick EG, Van Dyke RB, Smith R, Correia KF, DiPerna A, Seage GR 3rd, Hazra R, Crowell CS; Surveillance Monitoring for ART Toxicities (SMARTT) study of the Pediatric HIV/AIDS Cohort Study. Association of maternal antiretroviral use with microcephaly in children who are HIV-exposed but uninfected (SMARTT): a prospective cohort study. Lancet HIV. 2020 Jan;7(1):e49-e58. doi: 10.1016/S2352-3018(19)30340-6. Epub 2019 Nov 15.
Reference Type
RESULT
Powis KM, Huo Y, Williams PL, Kacanek D, Jao J, Patel K, Seage GR 3rd, Van Dyke RB, Chadwick EG; Pediatric HIV/AIDS Cohort Study (PHACS). Antiretroviral Prescribing Practices Among Pregnant Women Living With HIV in the United States, 2008-2017. JAMA Netw Open. 2019 Dec 2;2(12):e1917669. doi: 10.1001/jamanetworkopen.2019.17669.
Reference Type
RESULT
Pintye J, Huo Y, Kacanek D, Zhang K, Kuncze K, Okochi H, Gandhi M. Extent of In Utero Transfer of Tenofovir From Mother to Fetus: A Paired Analysis of Hair Specimens Collected at Birth From a Cohort in the United States. J Infect Dis. 2021 Feb 24;223(4):638-644. doi: 10.1093/infdis/jiaa398.
Reference Type
RESULT
Pintye J, Huo Y, Kacanek D, Zhang K, Kuncze K, Okochi H, Gandhi M; Pediatric HIV/AIDS Cohort Study (PHACS). Detectable HIV RNA in late pregnancy associated with low tenofovir hair levels at time of delivery among women living with HIV in the United States. AIDS. 2021 Feb 2;35(2):267-274. doi: 10.1097/QAD.0000000000002730.
Reference Type
RESULT
O'Brien BE, Williams PL, Huo Y, Kacanek D, Chadwick EG, Powis KM, Correia K, Haddad LB, Yee LM, Chakhtoura N, Dola C, Van Dyke RB; Pediatric HIV/AIDS Cohort Study (PHACS). Repeat Pregnancies Among US Women Living With HIV in the SMARTT Study: Temporal Changes in HIV Disease Status and Predictors of Preterm Birth. J Acquir Immune Defic Syndr. 2020 Nov 1;85(3):346-354. doi: 10.1097/QAI.0000000000002445.
Reference Type
RESULT
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):102. Epub 2016 Sep 5.
Reference Type
RESULT
Rice ML, Russell JS, Frederick T, Purswani M, Williams PL, Siberry GK, Redmond SM, Hoffman HJ, Yao TJ; Pediatric HIV/AIDS Cohort Study (PHACS). Risk for Speech and Language Impairments in Preschool Age HIV-exposed Uninfected Children With In Utero Combination Antiretroviral Exposure. Pediatr Infect Dis J. 2018 Jul;37(7):678-685. doi: 10.1097/INF.0000000000001875.
Reference Type
RESULT
Miller TL, Jacobson DL, Somarriba G, Neri D, Kurtz-Vraney J, Graham P, Gillman MW, Landy DC, Siminski S, Butler L, Rich KC, Hendricks K, Ludwig DA; Pediatric HIV/AIDS Cohort Study. A multicenter study of diet quality on birth weight and gestational age in infants of HIV-infected women. Matern Child Nutr. 2017 Oct;13(4):e12378. doi: 10.1111/mcn.12378. Epub 2016 Nov 8.
Reference Type
RESULT
Williams PL, Huo Y, Rutstein R, Hazra R, Rough K, Van Dyke RB, Chadwick EG. Trends in Neonatal Prophylaxis and Predictors of Combination Antiretroviral Prophylaxis in US Infants from 1990 to 2015. AIDS Patient Care STDS. 2018 Feb;32(2):48-57. doi: 10.1089/apc.2017.0295.
Reference Type
RESULT
Jao J, Kacanek D, Yu W, Williams PL, Patel K, Burchett S, Scott G, Abrams EJ, Sperling RS, Van Dyke RB, Smith R, Malee K; Pediatric HIV/AIDS Cohort Study. Neurodevelopment of HIV-Exposed Uninfected Infants Born to Women With Perinatally Acquired HIV in the United States. J Acquir Immune Defic Syndr. 2020 Jun 1;84(2):213-219. doi: 10.1097/QAI.0000000000002318.
Reference Type
RESULT
Crowell CS, Williams PL, Yildirim C, Van Dyke RB, Smith R, Chadwick EG, Seage GR 3rd, Diperna A, Hazra R; Pediatric HIV/AIDS Cohort Study. Safety of in-utero antiretroviral exposure: neurologic outcomes in children who are HIV-exposed but uninfected. AIDS. 2020 Jul 15;34(9):1377-1387. doi: 10.1097/QAD.0000000000002550.
Reference Type
RESULT
Labuda SM, Huo Y, Kacanek D, Patel K, Huybrechts K, Jao J, Smith C, Hernandez-Diaz S, Scott G, Burchett S, Kakkar F, Chadwick EG, Van Dyke RB; Pediatric HIV/AIDS Cohort Study. Rates of Hospitalization and Infection-Related Hospitalization Among Human Immunodeficiency Virus (HIV)-Exposed Uninfected Children Compared to HIV-Unexposed Uninfected Children in the United States, 2007-2016. Clin Infect Dis. 2020 Jul 11;71(2):332-339. doi: 10.1093/cid/ciz820.
Reference Type
RESULT
Lin SH, Wang Y, Hartley SW, Karyadi DM, Lee OW, Zhu B, Zhou W, Brown DW, Beilstein-Wedel E, Hazra R, Kacanek D, Chadwick EG, Marsit CJ, Poirier MC, Brummel SS, Chanock SJ, Engels EA, Machiela MJ; Pediatric HIV/AIDS Cohort Study. In-utero exposure to zidovudine-containing antiretroviral therapy and clonal hematopoiesis in HIV-exposed uninfected newborns. AIDS. 2021 Aug 1;35(10):1525-1535. doi: 10.1097/QAD.0000000000002894.
Reference Type
RESULT
Jacobson DL, Neri D, Gaskins A, Yee L, Mendez AJ, Hendricks K, Siminski S, Zash R, Hyzy L, Jao J; Pediatric HIV/AIDS Cohort Study. Maternal anemia and preterm birth among women living with HIV in the United States. Am J Clin Nutr. 2021 Jun 1;113(6):1402-1410. doi: 10.1093/ajcn/nqaa441.
Reference Type
RESULT
Smith C, Huo Y, Patel K, Fetters K, Hegemann S, Burchett S, Van Dyke R, Weinberg A. Immunologic and Virologic Factors Associated With Hospitalization in Human Immunodeficiency Virus-Exposed, Uninfected Infants in the United States. Clin Infect Dis. 2021 Sep 15;73(6):1089-1096. doi: 10.1093/cid/ciab272.
Reference Type
RESULT
Yee LM, Kacanek D, Brightwell C, Haddad LB, Jao J, Powis KM, Yao TJ, Barr E, Broadwell C, Siminski S, Seage GR 3rd, Chadwick EG; Pediatric HIV/AIDS Cohort Study. Marijuana, Opioid, and Alcohol Use Among Pregnant and Postpartum Individuals Living With HIV in the US. JAMA Netw Open. 2021 Dec 1;4(12):e2137162. doi: 10.1001/jamanetworkopen.2021.37162.
Reference Type
RESULT
Yu W, Jacobson DL, Williams PL, Patel K, Geffner ME, Van Dyke RB, Kacanek D, DiMeglio LA, Jao J; Pediatric HIV/AIDS Cohort Study (PHACS). Growth patterns of uninfected children born to women living with perinatally versus nonperinatally acquired HIV. AIDS. 2022 Mar 15;36(4):593-603. doi: 10.1097/QAD.0000000000003136.
Reference Type
RESULT
Young MR, Broadwell C, Kacanek D, Chadwick EG, Jao J, Moscicki AB, Powis K, Tassiopoulos K, Yee LM, Haddad LB; Pediatric HIV/AIDS Cohort Study. Sexually Transmitted Infections in Pregnant People With Human Immunodeficiency Virus: Temporal Trends, Demographic Correlates, and Association With Preterm Birth. Clin Infect Dis. 2022 Dec 19;75(12):2211-2218. doi: 10.1093/cid/ciac321.
Reference Type
RESULT
Yee LM, Jacobson DL, Haddad LB, Jao J, Powis KM, Kacanek D, Zash R, DiPerna A, Chadwick EG; Pediatric HIV/AIDS Cohort Study. Evaluating the association of antiretroviral therapy and immune status with hypertensive disorders of pregnancy among people with HIV. AIDS. 2023 Sep 1;37(11):1715-1723. doi: 10.1097/QAD.0000000000003607. Epub 2023 May 23.
Reference Type
RESULT
Jao J, Kacanek D, Broadwell C, Jacobson DL, Chadwick EG, Williams PL, Powis KM, Haddad LB, Yee L; Pediatric HIV/AIDS Cohort Study. Gestational weight gain in persons with HIV in the United States. AIDS. 2023 May 1;37(6):883-893. doi: 10.1097/QAD.0000000000003454. Epub 2022 Dec 2.
Reference Type
RESULT
Shiau S, Jacobson DL, Huo Y, Kacanek D, Yee LM, Williams DB, Haddad LB, Serghides L, Powis K, Sperling RS, Williams PL, Jao J; Pediatric HIV/AIDS Cohort Study. Unique Profile of Inflammation and Immune Activation in Pregnant People With HIV in the United States. J Infect Dis. 2023 Mar 1;227(5):720-730. doi: 10.1093/infdis/jiac501.
Reference Type
RESULT
Yao TJ, Malee K, Zhang J, Smith R, Redmond S, Rice ML, Frederick T, Torre P, Mellins CA, Hoffman HJ, Williams PL. In Utero Antiretroviral Exposure and Risk of Neurodevelopmental Problems in HIV-Exposed Uninfected 5-Year-Old Children. AIDS Patient Care STDS. 2023 Mar;37(3):119-130. doi: 10.1089/apc.2022.0189. Epub 2023 Feb 24.
Reference Type
RESULT
Davtyan M, Kacanek D, Lee J, Berman C, Chadwick EG, Smith R, Salomon L, Frederick T; Pediatric HIV/AIDS Cohort Study. The role of internalised HIV stigma in disclosure of maternal HIV serostatus to children perinatally HIV-exposed but uninfected: a prospective study in the United States. J Int AIDS Soc. 2023 Oct;26 Suppl 4(Suppl 4):e26167. doi: 10.1002/jia2.26167.
Reference Type
RESULT
Davtyan M, Kacanek D, Lee J, Berman C, Chadwick EG, Smith R, Salomon L, Frederick T; Pediatric HIV/AIDS Cohort Study. Factors associated with internalized HIV-related stigma among biological mothers living with HIV enrolled in a US cohort study. AIDS Care. 2024 Feb;36(2):220-226. doi: 10.1080/09540121.2023.2263680. Epub 2024 Jan 30.
Reference Type
RESULT
Fisher SA, Jao JK, Yee LM, Serghides L, Chadwick EG, Jacobson DL. Association of Fatty Acid Signatures with HIV Viremia in Pregnancy. AIDS Res Hum Retroviruses. 2024 Apr;40(4):257-267. doi: 10.1089/AID.2023.0040. Epub 2023 Oct 30.
Reference Type
RESULT
Berhie S, Kacanek D, Lee J, Jao J, Powis K, Salomon L, Siddiqui D, Yee LM; Pediatric HIV/AIDS Cohort Study. Routine Vaccination During Pregnancy Among People Living With HIV in the United States. JAMA Netw Open. 2024 May 1;7(5):e249531. doi: 10.1001/jamanetworkopen.2024.9531.
Reference Type
RESULT
Fung K, Hernandez-Diaz S, Zash R, Chadwick EG, Van Dyke RB, Broadwell C, Jao J, Powis K, Yee LM, Williams PL; Pediatrics HIV/AIDS Cohort Study (PHACS). First-trimester exposure to newer antiretroviral agents and congenital anomalies in a US cohort. AIDS. 2024 Sep 1;38(11):1686-1695. doi: 10.1097/QAD.0000000000003955. Epub 2024 Jun 11.
Reference Type
RESULT
Purswani MU, Jacobson DL, DiMeglio LA, Yao TJ, Kopp JB, Van Dyke RB, Yu W, Siberry GK; Pediatric HIV/AIDS Cohort Study (PHACS). Phosphaturia in HIV-Exposed Uninfected Neonates Associated with Maternal Use of Tenofovir Disoproxil Fumarate in Late Pregnancy. J Pediatric Infect Dis Soc. 2024 Aug 24;13(8):396-405. doi: 10.1093/jpids/piae054.
Reference Type
RESULT
Gojanovich GS, Marsit CJ, Kacanek D, Russell J, Hudson G, Van Dyke RB, Naini AB, Gerschenson M; Pediatric HIV/AIDS Cohort Study. Relationships of mitochondrial DNA mutations and select clinical diagnoses in perinatally HIV- and ART-exposed uninfected children. Mitochondrion. 2024 Nov;79:101949. doi: 10.1016/j.mito.2024.101949. Epub 2024 Aug 30.
Reference Type
RESULT
Olivero R, Williams PL, Sawyer G, Yee LM, Patel K, Hernandez-Diaz S, Powis K, Paul M, Chadwick EG; Pediatric HIV/AIDS Cohort Study and the HOPE study. Birth outcomes following bictegravir exposure during pregnancy. AIDS. 2025 Mar 15;39(4):381-386. doi: 10.1097/QAD.0000000000004041. Epub 2024 Oct 14.
Reference Type
RESULT
Related Links
Access external resources that provide additional context or updates about the study.
https://www.phacsstudy.org
Pediatric HIV/AIDS Cohort Study
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PH100
Identifier Type: OTHER
Identifier Source: secondary_id
1P01HD103133 - PH100
Identifier Type: -
Identifier Source: org_study_id
NCT00647803
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
The University of Zimbabwe College of Health Science (UZ-CHS) BIRTH COHORT Study
NCT04087239
ACTIVE_NOT_RECRUITING
Adolescent Master Protocol
NCT01418014
COMPLETED
Long Term Outcomes of Therapy in Women Initiated on Lifelong ART Because of Pregnancy in DR Congo
NCT03048669
COMPLETED
NA
A Study of Zidovudine in Infants Exposed to the HIV Before or Soon After Birth
NCT00001007
COMPLETED
PHASE1
Therapeutic Drug Monitoring and Viral Resistance Testing in the Treatment of HIV-Infected Children
NCT00032669
COMPLETED
PHASE1
Immune Function of Infants With HIV
NCT00073229
COMPLETED
POC HIV Testing and Early DTG Use for Infants
NCT05393193
ACTIVE_NOT_RECRUITING
PHASE4
Non-virologic Methods to Diagnose Treatment Eligibility in HIV-exposed Infants
NCT01222130
COMPLETED
Long-term Effects of Highly Active Anti-Retroviral Therapy on HIV-Infected Children
NCT00260806
COMPLETED
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
NCT01618305
COMPLETED
PHASE4
A Prospective, Observational Study of HIV-Infected Pregnant Women and Their Infants at Clinical Sites in Latin American and Caribbean Countries
NCT00341302
COMPLETED
Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
NCT06517693
RECRUITING
PHASE1
HIV Diagnosis and Treatment at Birth for Newborn With High Risk HIV Exposure
NCT03642704
COMPLETED
PHASE4
Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
NCT00115648
COMPLETED
PHASE3
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
NCT05406583
COMPLETED
PHASE1
Stopping and Restarting Anti-HIV Drugs in Children and Adolescents With Low Blood Levels of HIV
NCT00016783
COMPLETED
Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
NCT00000828
COMPLETED
A Study to Collect Information About HIV-Positive Pregnant Women and Their Babies
NCT00000910
COMPLETED
HIV Exposure in Utero and Metabolic Disease Risk in HIV-Negative Young Adults
NCT04132830
COMPLETED
IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
NCT00955968
COMPLETED
PHASE4
A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.
NCT00000855
COMPLETED
NA
Monitoring Highly Active Antiretroviral Therapy in HIV-infected Parents in Thailand
NCT00162682
COMPLETED
PHASE3
Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants
NCT00038480
COMPLETED
PHASE1
Antiretroviral Adherence Evaluation in HIV Pregnant and Postpartum Women
NCT01621347
COMPLETED
HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV
NCT00442962
COMPLETED
PHASE4