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RecruitingNCT02140255Updated Sep 9, 2026

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

A Phase 1/2 interventional study of Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and Nevirapine (NVP) in HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 47 sites in 13 countries. Open to participants aged Up to 48 Hours. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
1,120
Allocation
Non-randomized
Ages
Up to 48 Hours
Sex
All
01

Study summary

The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.

Read the detailed description

The purpose of this study is to explore the effects of early intensive antiretroviral therapy (ART) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.

The study will enroll two cohorts. Cohort 1 will include infants born to a mother with presumed or confirmed HIV infection who received no or very limited antiretrovirals during pregnancy. Cohort 2 will include infants with at least one positive HIV nucleic acid test result from a sample collected within 48 hours of birth who initiated a qualifying ART regimen within 48 hours of birth.

Seven early intensive therapy regimens will be assessed. Regimen 1L will include 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus nevirapine (NVP) plus lopinavir/ritonavir (LPV/r). Regimen 2R will include 2 NRTIs plus NVP plus raltegravir (RAL). Regimen 2RV will include 2 NRTIs plus NVP plus RAL plus VRC01 monoclonal antibody. Regimen 3RD will include 2 NRTIs plus NVP plus RAL with subsequent switch to 2 NRTIs plus dolutegravir (DTG) upon reaching 28 days of age and 3 kg body weight. Regimen 3RDV7 will include 2 NRTIs plus NVP plus RAL plus VRC07-523LS with subsequent switch to 2 NRTIs plus DTG plus VRC07-523LS upon reaching 28 days of age and 3 kg body weight. Regimen 4D will include 2 NRTIs plus DTG. Regimen 4DV7 will include 2 NRTIs plus DTG plus VRC07-523LS.

The study will be conducted in four steps. In Step 1, Cohort 1 infants will be enrolled for evaluation of HIV infection and initiation of early intensive therapy within 48 hours of birth. Infants in whom in utero HIV infection is excluded will switch from the study regimen to standard perinatal prophylaxis per local guidelines within two weeks; these infants will continue in Step 1 safety monitoring for two additional weeks, undergo HIV testing at approximately 24 weeks of age, and then exit the study. Infants in whom in utero HIV infection is confirmed will enter Step 2 at least two weeks after enrollment in Step 1.

In Step 2, infants will receive the study regimen for up to 192 weeks. Beginning at Step 2 Week 84, children who achieved HIV RNA suppression by Week 24, and maintained suppression, thereafter, will be evaluated for possible analytic treatment interruption (ATI).

In Step 3, children in Step 2 who meet criteria for ATI will interrupt ART and be closely monitored for viral rebound for up to ten years.

In Step 4, children who experience viral rebound in Step 3 or meet other Step 4 inclusion criteria will re-initiate ART and be closely monitored for viral re-suppression on ART until five years of age or six months after re-suppression, whichever is later.

02

Conditions studied

  • HIV Infection

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Keywords

  • HIV Remission
03

Who can participate

Ages eligible
Up to 48 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Maternal Inclusion Criteria

  1. Presumed or confirmed maternal HIV infection:

    • Mothers will be eligible to enroll with EITHER:

      • Presumed HIV infection defined as at least one positive rapid HIV antibody-based test result from a sample collected in the peripartum period. Presumed infection must be confirmed within 10 business days of enrollment OR
      • Confirmed HIV infection defined as positive results from two samples collected at different timepoints
  2. Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with IRB/EC policies and procedures. Otherwise, informed consent must be obtained from a legal guardian and the mother must provide written assent.
  3. Was not previously enrolled in this study with another infant.
  4. Did not receive ARVs during the current pregnancy.
  5. Infant is eligible per inclusion criteria.

Infant Inclusion Criteria for Step 1

  1. Less than or equal to 48 hours of age.
  2. Greater than or equal to 37 weeks gestational age at birth (assessment of gestational age will be based on the best clinical estimate determined by date of last menstrual period, antenatal ultrasound, fundal height, or Ballard Score).
  3. Greater than or equal to 2 kilograms (kg) at birth.
  4. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.
  5. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.
  6. Mother is eligible per inclusion criteria.

Infant Inclusion Criteria for Step 2

  1. Enrolled in Step 1.
  2. Confirmed in utero HIV infection.
  3. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.
  4. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.
  5. Mother (or legal guardian if applicable) is willing and able to provide written informed consent for child's participation in Step 2.

Infant Inclusion Criteria for Step 3

  1. Enrolled in Step 2.
  2. Has reached Step 2 Week 96.

  3. Has the following results based on testing:

    • No confirmed plasma HIV RNA ≥200 copies/mL at Step 2 Week 24 and up to but excluding Step 2 Week 48.

    • No plasma HIV RNA detected at Step 2 Week 48 and thereafter, with two possible exceptions

      • (i) First possible exception: If HIV RNA is detected at or after Step 2 Week 48 with a result \<200 copies/mL, testing will be repeated within three weeks (specimen collection for the confirmatory test must occur within three weeks of specimen collection for the initial test).
      • If no HIV RNA is detected on the confirmatory test, or if HIV RNA is detected with a result \<200 copies/mL, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2, provided no HIV RNA is detected on any subsequent tests in Step 2.
      • If HIV RNA is detected on the confirmatory test with a result ≥200 copies/mL, the infant will not be eligible for Step 3.
      • (ii) Second possible exception: If HIV RNA is detected after Step 2 Week 48 with a result \<LOD, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2 with no RNA detected. There is no limit on the number of times HIV RNA may be detected with a result \<LOD after Week 48. However, infants with detectable RNA with a result \<LOD after Week 48 will not be considered for entry into Step 3 until after an additional 48 weeks of no RNA detected.
      • Participants may experience either or both exceptions at different timepoints during follow-up in Step 2.
  4. If breastfed, must have permanently ceased breastfeeding, with no exposure to breast milk for at least six weeks prior to specimen collection for the testing specified in the criterion (#5) below.

  5. Has met ALL of the following additional criteria while in Step 2, based on testing between Step 2 Week 84 and Step 2 Week 192 (inclusive):

    • Two consecutive negative HIV antibody tests by fourth generation ELISA at least eight weeks apart.
    • Two consecutive HIV DNA tests with no DNA detected in at least 850,000 PBMCs assayed at least eight weeks apart.
    • CD4 cell percentage greater than or equal to 25% and CD4 cell absolute count greater than or equal to the lower limit of normal for age (≥1000 cells/mL if 2 to less than 3 years of age; ≥750 cells/mL if 3 to less than 5 years of age; ≥500 cells/mL if 5 years of age or older).
    • Infant assessed by the site investigator or designee as expected to adhere to the Step 3 Schedule of Evaluations.
    • Mother (or legal guardian if applicable) willing and able to provide written informed consent for child's participation in Step 3 and Step 4.
  6. No plasma HIV RNA detected by testing after criteria have been confirmed, with specimen collection for the assay within 14 days prior to Step 3 Entry.

Infant Inclusion Criteria for Step 4

  1. Enrolled in Step 3.

  2. Has met at least one of the following:

    • Plasma HIV RNA ≥LOD based on two assays.
    • Plasma HIV RNA ≥1000 copies/mL in the presence of fever or other sign or symptom of acute retroviral syndrome.
    • Confirmed or suspected diagnosis of acute retroviral syndrome.
    • Confirmed or suspected diagnosis of a new WHO Clinical Stage 3 or 4 condition.
    • Confirmed CD4 cell percentage less than 25% and CD4 cell absolute count less than the lower limit of normal for age (\<1000 cells/mL if 2 to less than 3 years of age; \<750 cells/mL if 3 to less than 5 years of age; \<500 cells/mL if 5 years of age or older).
    • Otherwise assessed by the site investigator or designee, in consultation with the Clinical Management Committee (CMC), as having an indication to re-initiate treatment.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
1,120 participants (estimated)

Study arms

  • Experimental
    Cohort 1, Regimen 1L: 2 NRTIs + NVP + LPV/r

    Participants will receive 2 NRTIs + NVP + LPV/r.

    Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) · Drug: Nevirapine (NVP) · Drug: Lopinavir/Ritonavir (LPV/r)

  • Experimental
    Cohort 2, Regimen 1L: 2 NRTIs + NVP + LPV/r

    Participants will receive 2 NRTIs + NVP + LPV/r.

    Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) · Drug: Nevirapine (NVP) · Drug: Lopinavir/Ritonavir (LPV/r)

  • Experimental
    Cohort 1, Regimen 2R: 2 NRTIs + NVP + RAL

    Participants will receive 2 NRTIs + NVP + RAL.

    Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) · Drug: Nevirapine (NVP) · Drug: Raltegravir (RAL)

  • Experimental
    Cohort 2, Regimen 2R: 2 NRTIs + NVP + RAL

    Participants will receive 2 NRTIs + NVP + RAL.

    Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) · Drug: Nevirapine (NVP) · Drug: Raltegravir (RAL)

  • Experimental
    Cohort 1, Regimen 2RV: 2 NRTIs + NVP + RAL + VRC01

    Participants will receive 2 NRTIs + NVP + RAL + VRC01.

    Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) · Drug: Nevirapine (NVP) · Drug: Raltegravir (RAL) · Drug: VRC01

  • Experimental
    Cohort 1, Regimen 3RD: 2 NRTIs + NVP + RAL switch to 2 NRTIs + DTG

    Participants will receive 2 NRTIs + NVP + RAL with subsequent switch to 2 NRTIs + DTG upon reaching 28 days of age and 3 kg body weight.

    Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) · Drug: Nevirapine (NVP) · Drug: Raltegravir (RAL) · Drug: Dolutegravir (DTG)

  • Experimental
    Cohort 1, Regimen 3RDV7: 2 NRTIs + NVP + RAL + VRC07-523LS switch to 2 NRTIs + DTG + VRC07-523LS

    Participants will receive 2 NRTIs + NVP + RAL + VRC07-523LS with subsequent switch to 2 NRTIs + DTG + VRC07-523LS upon reaching 28 days of age and 3 kg body weight.

    Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) · Drug: Nevirapine (NVP) · Drug: Raltegravir (RAL) · Drug: Dolutegravir (DTG) · Drug: VRC07-523LS

  • Experimental
    Cohort 1, Regimen 4D: 2 NRTIs + DTG

    Participants will receive 2 NRTIs + DTG

    Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) · Drug: Dolutegravir (DTG)

  • Experimental
    Cohort 1, Regimen 4DV7: 2 NRTIs + DTG + VRC07-523LS

    Participants will receive 2 NRTIs + DTG + VRC07-523LS

    Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) · Drug: Dolutegravir (DTG) · Drug: VRC07-523LS

Interventions

  • DrugNucleoside Reverse Transcriptase Inhibitors (NRTIs)

    Chosen by the site investigator and dosed according to World Health Organization (WHO) or individual country or local standard guidelines.

  • DrugNevirapine (NVP)

    Administered orally. Dosed according to study step/participant's age/participant's weight.

  • DrugLopinavir/Ritonavir (LPV/r)

    Administered orally. Dosed according to study step and participant's age.

  • DrugRaltegravir (RAL)

    Administered orally. Dosed according to study step and participant's age.

  • DrugVRC01

    40 mg/kg administered subcutaneously.

  • DrugDolutegravir (DTG)

    Dosed according to study step/participant's age/participant's weight

  • DrugVRC07-523LS

    40 mg/kg administered subcutaneously.

05

What researchers measure

Primary outcomes

  1. Number of participants who achieve HIV remission

    Defined as no confirmed HIV RNA greater than or equal to the limit of detection (LOD) through 48 weeks of treatment interruption

    Time frame: Measured through Week 48

Secondary outcomes

  1. Frequency of Grade 3 or higher adverse events possibly, probably or definitely related to any component of the study regimen

    Graded according to the DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

    Time frame: Measured through Week 192

  2. Number of participants with viral suppression to consistent HIV-1 RNA less than LOD

    Based on laboratory evaluations

    Time frame: Measured through Week 24

  3. Number of participants meeting all eligibility criteria for treatment interruption

    As defined in criteria described in study protocol

    Time frame: Measured through Week 192

  4. Number of infants meeting the selected eligibility criteria for treatment interruption among infants who also met the viral suppression criteria for treatment interruption.

    As defined in criteria described in the study protocol

    Time frame: Measured through Week 192

  5. Number of participants who experience HIV persistence

    As measured by plasma viremia (single copy), droplet digital DNA, replication competent HIV reservoirs

    Time frame: Measured through Week 48

Other outcomes

  1. Change in HIV-specific immune response

    As measured by %CD8+/DR+ T cells

    Time frame: Measured through Week 48

  2. Change in immune activation markers (%CD8+/DR+ T cells) response

    As measured by HIV-specific antibodies and HIV-specific T cell responses

    Time frame: Measured through Week 48

  3. Change in DTG concentration among treated neonates and young infants

    Based on laboratory evaluations

    Time frame: Measured through Week 24

  4. Change in VRC07-523LS concentration among treated neonates and young infants

    Based on laboratory evaluations

    Time frame: Measured through Week 24

  5. Presence of ARV genotypic resistance to drugs taken

    Time frame: Measured through Week 48

  6. Presence of bNAb resistance as measured by inhibitory concentration

    Time frame: Measured through Week 48

06

Study locations

25 of 47 sites recruiting
  • 4601, University of California, San Diego Clinical Research Site
    La Jolla, California 92093-0672, United States
    Completed
  • 5048, University of Southern California Clinical Research Site
    Los Angeles, California 90089, United States
    • Yvonne A. Morales · Contact · ytr@usc.edu · (323) 865-1561
    Recruiting
  • 5112, David Geffen School of Medicine at UCLA Clinical Research Site
    Los Angeles, California 90095-1752, United States
    Recruiting
  • 5052, University of Colorado, Denver Clinical Research Site
    Aurora, Colorado 80045, United States
    Recruiting
  • 5055, South Florida CDTC Fort Lauderdale Clinical Research Site
    Fort Lauderdale, Florida 33316, United States
    Completed
  • 5051, University of Florida Center for HIV/AIDS Research, Education and Service (UF CARES) Clinical Research Site
    Jacksonville, Florida 32209, United States
    Recruiting
  • 5127, Pediatric Perinatal HIV Clinical Research Site
    Miami, Florida 33136, United States
    Withdrawn
  • Emory University School of Medicine NICHD CRS
    Atlanta, Georgia 30322, United States
    Withdrawn
  • 32515, Rush Univ./Cook County Hosp. Chicago CRS
    Chicago, Illinois 60612, United States
    Recruiting
  • 5083, Rush University Cook County Hospital Clinical Research Site
    Chicago, Illinois 60612, United States
    Withdrawn
  • 4001, Lurie Children's Hospital of Chicago Clinical Research Site
    Chicago, Illinois 60614-3393, United States
    Recruiting
  • 5092, Johns Hopkins Clinical Research Site
    Baltimore, Maryland 21287, United States
    Recruiting
  • Boston Medical Center Ped. HIV Program NICHD CRS
    Boston, Massachusetts 02118, United States
    Withdrawn
  • 5040, SUNY Stony Brook Clinical Research Site
    Stony Brook, New York 11794, United States
    Withdrawn
  • 5114, Bronx Lebanon Hospital Center Clinical Research Site
    The Bronx, New York 10457, United States
    Recruiting
  • 5013, Jacobi Medical Center Clinical Research Site
    The Bronx, New York 10461, United States
    Recruiting
  • Philadelphia IMPAACT Unit CRS
    Philadelphia, Pennsylvania 9104, United States
    Withdrawn
  • 6501, St Jude Children's Research Hospital Clinical Research Site
    Memphis, Tennessee 38105-3678, United States
    Recruiting
  • 5128, Baylor College of Medicine/Texas Children's Hospital Clinical Research Site
    Houston, Texas 77030, United States
    Recruiting
  • Seattle Children's Research Institute CRS
    Seattle, Washington 98101, United States
    Withdrawn
  • Univ. of Washington NICHD CRS
    Seattle, Washington 98195, United States
    Withdrawn
  • Hosp. General de Agudos Buenos Aires Argentina NICHD CRS
    Buenos Aires, C1221ADC, Argentina
    Withdrawn
  • Hospital Nossa Senhora da Conceicao NICHD CRS
    Porto Alegre, Rio Greande Do Sul 91350-200, Brazil
    Completed
  • 5073, School of Medicine Federal University Minas Gerais Clinical Research Site
    Minas Gerais, 30.130-100, Brazil
    Recruiting
  • 5072, Hospital Federal dos Servidores do Estado Clinical Research Site
    Rio de Janeiro, 20221-903, Brazil
    Completed
  • 5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site
    Rio de Janeiro, 21941-612, Brazil
    Recruiting
  • 5097, Hospital Geral de Nova Igaucu Clinical Research Site
    Rio de Janeiro, 26030, Brazil
    Completed
  • 5074, University of Sao Paulo Clinical Research Site
    São Paulo, 14049-900, Brazil
    Completed
  • 30022, Les Centres GHESKIO Clinical Research Site
    Port-au-Prince, HT-6110, Haiti
    Recruiting
  • 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center Kericho Clinical Research Site
    Kericho, 20200, Kenya
    Recruiting
  • 12001, Malawi Clinical Research Site
    Lilongwe, Central Region, Malawi
    Recruiting
  • 30301, Blantyre Clinical Research Site
    Blantyre, Malawi
    Recruiting
  • 32513, IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research Network CRS
    San Juan, PR 00935, Puerto Rico
    Withdrawn
  • San Juan City Hosp. PR NICHD CRS
    San Juan, Puerto Rico 00936, Puerto Rico
    Withdrawn
  • Soweto IMPAACT CRS
    Johannesburg, Gauteng 1862, South Africa
    Completed
  • Wits RHI Shandukani Research Centre CRS
    Johannesburg, Gauteng 2001, South Africa
    Completed
  • 30300, Umlazi Clinical Research Site
    Durban, KwaZulu-Natal 4001, South Africa
    Recruiting
  • 8950, FAMCRU Clinical Research Site
    Tygerberg, Western Cape 7505, South Africa
    Completed
  • 5118, Kilimanjaro Christian Medical Centre Clinical Research Site
    Moshi, Tanzania
    Recruiting
  • 5115, Siriraj Hospital Mahidol University Clinical Research Site
    Bangkok, Bangkoknoi 10700, Thailand
    Recruiting
  • 5116, Chiangrai Prachanukroh Hospital Clinical Research Site
    Chiang Mai, 50100, Thailand
    Recruiting
  • 31798, Baylor-Uganda Clinical Research Site
    Kampala, Uganda
    Recruiting
  • MU-JHU Care Limited CRS
    Kampala, Uganda
    Completed
  • George CRS
    Lusaka, 10101, Zambia
    Completed
  • 30303, Saint Mary's Clinical Research Site
    Chitungwiza, Zimbabwe
    Recruiting
  • 30306, Seke North Clinical Research Site
    Chitungwiza, Zimbabwe
    Recruiting
  • 31890, Harare Family Care Clinical Research Site
    Harare, Zimbabwe
    Recruiting
07

References and documents

Publications

  • Persaud D, Bryson Y, Nelson BS, Tierney C, Cotton MF, Coletti A, Jao J, Spector SA, Mirochnick M, Capparelli EV, Costello D, Szewczyk J, Nicodimus N, Stranix-Chibanda L, Kekitiinwa AR, Korutaro V, Reding C, Carrington MN, Majji S, Yin DE, Jean-Philippe P, Chadwick EG. HIV-1 reservoir size after neonatal antiretroviral therapy and the potential to evaluate antiretroviral-therapy-free remission (IMPAACT P1115): a phase 1/2 proof-of-concept study. Lancet HIV. 2024 Jan;11(1):e20-e30. doi: 10.1016/S2352-3018(23)00236-9. Epub 2023 Dec 4. PubMed 38061376 ↗
  • Nelson BS, Tierney C, Persaud D, Jao J, Cotton MF, Bryson Y, Coletti A, Ruel TD, Spector SA, Reding C, Bacon K, Costello D, Perlowski C, Santos Cruz ML, Kosgei J, Majji S, Yin DE, Jean-Philippe P, Chadwick EG; IMPAACT P1115 Team. Infants Receiving Very Early Antiretroviral Therapy Have High CD4 Counts in the First Year of Life. Clin Infect Dis. 2023 Feb 8;76(3):e744-e747. doi: 10.1093/cid/ciac695. PubMed 36031390 ↗
  • Ruel TD, Capparelli EV, Tierney C, Nelson BS, Coletti A, Bryson Y, Cotton MF, Spector SA, Mirochnick M, LeBlanc R, Reding C, Zimmer B, Persaud D, Bwakura-Dangarembizi M, Naidoo KL, Hazra R, Jean-Philippe P, Chadwick EG. Pharmacokinetics and safety of early nevirapine-based antiretroviral therapy for neonates at high risk for perinatal HIV infection: a phase 1/2 proof of concept study. Lancet HIV. 2021 Mar;8(3):e149-e157. doi: 10.1016/S2352-3018(20)30274-5. Epub 2020 Nov 23. PubMed 33242457 ↗
  • Persaud D, Coletti A, Nelson BS, Jao J, Capparelli EV, Costello D, Tierney C, Kekitiinwa AR, Nematadzira T, Njau BN, Moye J, Jean-Philippe P, Korutaro V, Nalugo A, Mbengeranwa T, Chidemo T, Mmbaga BT, Sakasaka PA, Cotton M, Jennings C, Hoffmann C, Hovind L, Bryson Y, Chadwick EG; IMPAACT P1115 Study Team. ART-free HIV-1 remission in children with in-utero HIV-1 after very early ART (IMPAACT P1115): a multicentre, open-label, phase 1/2 proof-of-concept study. Lancet HIV. 2025 Nov;12(11):e743-e752. doi: 10.1016/S2352-3018(25)00189-4. Epub 2025 Sep 25. PubMed 41015049 ↗

Individual participant data

Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification.

Supporting information: Study protocol, Sap

08

Registry details

Key details

Study ID
NCT02140255
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
May 16, 2014
Start date
Jan 23, 2015
Primary completion
Jan 31, 2028 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Sep 9, 2026

Study contacts

Anne Coletti, MS
Contact
acoletti@fhi360.org
919-627-6445
Ellen Chadwick, MD
study chair · Northwestern University Feinberg School of Medicine and Ann & Robert Lurie Children's Hospital of Chicago
Jennifer Jao, MD
study chair · Northwestern University Feinberg School of Medicine and Ann & Robert Lurie Children's Hospital of Chicago

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
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