RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Quick Facts

Study Start:2015-01-23
Study Completion:2031-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02140255

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 48 Hours
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Anne Coletti, MS
CONTACT
919-627-6445
acoletti@fhi360.org

Principal Investigator

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

Study Locations (Sites)

4601, University of California, San Diego Clinical Research Site
La Jolla, California, 92093-0672
United States
5048, University of Southern California Clinical Research Site
Los Angeles, California, 90089
United States
5112, David Geffen School of Medicine at UCLA Clinical Research Site
Los Angeles, California, 90095-1752
United States
5052, University of Colorado, Denver Clinical Research Site
Aurora, Colorado, 80045
United States
5055, South Florida CDTC Fort Lauderdale Clinical Research Site
Fort Lauderdale, Florida, 33316
United States
5051, University of Florida Center for HIV/AIDS Research, Education and Service (UF CARES) Clinical Research Site
Jacksonville, Florida, 32209
United States
5127, Pediatric Perinatal HIV Clinical Research Site
Miami, Florida, 33136
United States
University of Miami CRS
Miami, Florida, 33136
United States
Emory University School of Medicine NICHD CRS
Atlanta, Georgia, 30322
United States
5083, Rush University Cook County Hospital Clinical Research Site
Chicago, Illinois, 60612
United States
4001, Lurie Children's Hospital of Chicago Clinical Research Site
Chicago, Illinois, 60614-3393
United States
5092, Johns Hopkins Clinical Research Site
Baltimore, Maryland, 21287
United States
Boston Medical Center Ped. HIV Program NICHD CRS
Boston, Massachusetts, 02118
United States
5114, Bronx Lebanon Hospital Center Clinical Research Site
Bronx, New York, 10457
United States
5013, Jacobi Medical Center Clinical Research Site
Bronx, New York, 10461
United States
5040, SUNY Stony Brook Clinical Research Site
Stony Brook, New York, 11794
United States
Philadelphia IMPAACT Unit CRS
Philadelphia, Pennsylvania, 9104
United States
6501, St Jude Children's Research Hospital Clinical Research Site
Memphis, Tennessee, 38105-3678
United States
Texas Children's Hospital CRS
Houston, Texas, 77030-2399
United States
5128, Baylor College of Medicine/Texas Children's Hospital Clinical Research Site
Houston, Texas, 77030
United States
Seattle Children's Research Institute CRS
Seattle, Washington, 98101
United States
Univ. of Washington NICHD CRS
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-01-23
Study Completion Date2031-12-31

Study Record Updates

Study Start Date2015-01-23
Study Completion Date2031-12-31

Terms related to this study

Keywords Provided by Researchers

  • HIV Remission

Additional Relevant MeSH Terms

  • HIV Infection