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Clinical Trials

MainTitle

IMPAACT P1115: Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2017 by International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Sponsor
International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier
NCT02140255

First received: May 13, 2014
Last updated: July 11, 2017
Last Verified: July 2017
History of Changes
Purpose

Purpose

IMPAACT P1115 will explore the effects of early intensive antiretroviral therapy (ART) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among HIV-infected infants.

Condition Intervention Phase
HIV Infection

Drug : Intensive ART regimen
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IMPAACT P1115: Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Primary Outcome Measures

  • HIV remission [ Time Frame: 48 weeks after ART cessation ]
    No confirmed HIV RNA at or above the level of detection of the RNA PCR assay
Secondary Outcome Measures:
  • Adverse events [ Time Frame: Through 5 years of age ]
    Grade 3, 4, and 5 signs, symptoms, laboratory values, and diagnoses assessed as possibly, probably, or definitely related to one or more ARVs

Estimated Enrollment: 472
Study Start Date: January 2015
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: Early Intensive ART

Drug: Intensive ART regimen
  • Nucleoside reverse transcriptase inhibitor (1) chosen by clinician
  • Nucleoside reverse transcriptase inhibitor (2) chosen by clinician
  • Nevirapine
  • Lopinavir boosted with ritonavir

Detailed Description:

IMPAACT P1115 will explore the effects of early intensive ART on achieving HIV remission (HIV RNA below the limit of detection of detection of the PCR assay) among infants infected with HIV in utero. Infants in this study will initiate ART within 48 hours of birth and will first be evaluated to determine whether HIV RNA can be detected in their blood while they are on ART. Upon reaching two years of age, infants with undetectable HIV RNA will be evaluated to determine if they meet study criteria to stop taking ART. Infants who meet these criteria will stop taking ART and will be monitored closely to determine whether HIV RNA remains undetectable while they are off ART. For any infant who stops ART and then has HIV RNA detected, ART will be re-started.
The study will also assess the safety and pharmacokinetics of early intensive ART in infants.

Eligibility

Eligibility

Ages Eligible for Study: up to 10 Days  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  1. COHORT 1 MOTHERS
    • Presumed or confirmed HIV infection (if presumed, must be confirmed within 7 days after study entry)
    • No receipt of ARVs during the current pregnancy.
    • Willing and able to provide written informed consent for maternal and infant study participation
  2. COHORT 1 INFANTS
    • ≤ 48 hours of age
    • ≥ 34 weeks gestational age at birth
    • Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube
  3. COHORT 2 MOTHERS
    • Presumed or confirmed HIV infection (if presumed, must be confirmed within 7 days after study entry)
    • Willing and able to provide written informed consent for maternal and infant study participation
  4. COHORT 2 INFANTS
    • ≤ 10 days of age
    • ≥ 34 weeks gestational age at birth
    • ≥ one nucleic acid test positive for HIV infection on a sample drawn within 48 hours of birth
    • Started ART within 48 hours of birth on a regimen including 2 NRTIs plus NVP at a dose of at least 8 mg/day for infants weighing ≤ 2 kg or 12 mg/day for infants > 2 kg AND/OR LPV/r
    • ART regimen was taken daily from date of initiation until study entry
    • Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube

  • Exclusion Criteria:

  • INFANTS
  • Any 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 investigator's opinion, would interfere with study participation or interpretation.

    contacts and locations

    Contacts and Locations

    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, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT02140255

    Contacts

    Contact:   Anne Coletti, MS 919-544-7040 ext 11238 acoletti@fhi360.org

    Locations

    United States, Florida
    Children's Diagnostic and Treatment Center(5055) Recruiting
    Fort Lauderdale, Florida, United States
    Contact: Ana Puga, MD    954-728-1017    apuga@browardhealth.org
    Contact: Zulma Eysallenne, RN    954-728-1125    zeysallenne@browardhealth.org
    Principal Investigator: Ana Puga, MD
    University of Florida Center for HIV/AIDS Research, Education, and Service (5051) Recruiting
    Jacksonville, Florida, United States
    Contact: Mobeen Rathore, MD    904-244-2120    mobeen.rathore@jax.ufl.edu
    Contact: Tabetha Gayton, RN, PhD    904-244-5331    tabetha.gayton@jax.ufl.edu
    Principal Investigator: Mobeen Rathore, MD
    University of Miami Pediatric/Perinatal HIV Clinical Research Site (4201) Recruiting
    Miami, Florida, United States
    Contact: Gwendolyn Scott, MD    305-243-6522    gscott@med.miami.edu
    Contact: Patricia Bryan, RN    305-243-2700    pbryan@med.miami.edu
    Principal Investigator: Gwendolyn Scott, MD
    United States, Illinois
    Ann & Robert H. Lurie Children's Hospital of Chicago (4001) Recruiting
    Chicago, Illinois, United States
    Contact: Ellen Chadwick, MD    312-227-4080    egchadwick@luriechildrens.org
    Contact: Margaret Ann Sanders, MPH    312-227-8275    msanders@luriechildrens.org
    Principal Investigator: Ellen Chadwick, MD
    United States, Maryland
    Johns Hopkins University School of Medicine (5092) Recruiting
    Baltimore, Maryland, United States
    Contact: Allison Agwu, MD, MS    410-614-3917    ageorg10@jhmi.edu
    Contact: Thuy Anderson, RN, BSN    443-287 8942    tander34@jhmi.edu
    Principal Investigator: Allison Agwu, MD
    United States, Massachusetts
    Boston Medical Center (5011) Recruiting
    Boston, Massachusetts, United States
    Contact: Cooper Ellen, MD    617-414-5588    ercooper@bu.edu
    Contact: Debra McLaud, RN    617-414-5813    demclaud@bmc.org
    Principal Investigator: Ellen Cooper, MD
    United States, New York
    SUNY Stony Brook University Medical Center (5040) Recruiting
    Stony Brook, New York, United States
    Contact: Sharon Nachman, MD    631-444-7692    sharon.nachman@sbumed.org
    Contact: Denise Ferraro    631-444-8225    denise.ferraro@stonybrook.edu
    Principal Investigator: Sharon Nachman, MD
    Jacobi Medical Center (5013) Recruiting
    The Bronx, New York, United States
    Contact: Andrew Wiznia, MD    718-918-4903    andrew.wiznia@einstein.yu.edu
    Contact: Marlene Burey    718-918-4783    marlene.burey@nbhn.net
    Principal Investigator: Andrew Wiznia, MD
    United States, Tennessee
    St Jude Children's Research Hospital (6501) Recruiting
    Memphis, Tennessee, United States
    Contact: Katherine Knapp, MD    901-448-4774    Katherine.knapp@stjude.org
    Contact: Jill Utech, MSN, CCRC    901-595-3490    jill.utech@stjude.org
    Principal Investigator: Katherine Knapp, MD
    Puerto Rico
    San Juan City Hospital (5031) Recruiting
    San Juan, Puerto Rico
    Contact: Midnela Acevedo-Flores, MT, MD    787-764-3083    macevedo@sanjuanciudadpatria.com
    Contact: Elvia Perez, BS, MA, MPH    787-764-3083    eperez@sanjuanciudadpatria.com
    Principal Investigator: Midnela Acevedo-Flores, MT, MD

    Sponsors and Collaborators

    International Maternal Pediatric Adolescent AIDS Clinical Trials Group
    National Institute of Allergy and Infectious Diseases (NIAID)
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    Study Chair: Yvonne Bryson, MD University of California, Los Angeles
    Study Chair: Ellen Chadwick, MD Northwestern University Feinberg School of Medicine and Ann & Robert Lurie Children's Hospital of Chicago
    More Information

    More Information

    Additional Information:

    Related Info

    Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group  
    ClinicalTrials.gov Identifier: NCT02140255   History of Changes  
    Other Study ID Numbers: IMPAACT P1115  
      UM1AI068632  
      UM1AI068616  
      UM1AI106716  
    Study First Received: May 13, 2014  
    Last Updated: July 11, 2017  

    Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

    HIV Remission

    Additional relevant MeSH terms:
    HIV Infections
    Reverse Transcriptase Inhibitors

    ClinicalTrials.gov processed this data on October 16, 2017
    This information is provided by ClinicalTrials.gov.