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Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV

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ClinicalTrials.gov Identifier: NCT05154513
Recruitment Status : Recruiting
First Posted : December 13, 2021
Last Update Posted : February 7, 2022
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Brief Summary:
IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure. Up to approximately 250 participants will be in the study for approximately seven years. No intervention is provided in the study.

Condition or disease Intervention/treatment
HIV Infection Other: Cohort 1

Detailed Description:

This is an observational prospective cohort study characterizing and establishing a biorepository of early treated children who may participate in future research related to HIV remission or cure. Early treatment is defined as treatment with at least three ARV agents from at least two classes of ART initiated within 12 weeks of birth. Within the overall study population, for descriptive and analysis purposes, children who initiated treatment within 48 hours of birth will be classified as having received very early treatment. A subset of children will have received bNAbs as part of their treatment regimens.

Up to approximately 250 children living with HIV who received early treatment in IMPAACT network studies or other research studies sponsored by the US National Institutes of Health (NIH) will be enrolled and followed semi-annually for up to seven years. Clinical, virologic, and immunologic evaluations will be performed semi-annually at each study visit, and specimens will be collected for the study's biorepository for future investigations.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
Actual Study Start Date : February 2, 2022
Estimated Primary Completion Date : November 30, 2027
Estimated Study Completion Date : November 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Cohort 1
Children living with perinatally-acquired HIV who received early treatment in IMPAACT network studies or other research studies sponsored by the United States National Institutes of Health.
Other: Cohort 1
No intervention provided in this study




Primary Outcome Measures :
  1. Clinical Outcome Measures - Weight measured in kg [ Time Frame: At enrollment, at participant study completion (up until 7 years) ]
    Median and interquartile range; to characterize long-term clinical profile

  2. Clinical Outcome Measures - Height measured in cm [ Time Frame: At enrollment, at participant study completion (up until 7 years) ]
    Median and interquartile range; to characterize long-term clinical profile

  3. Clinical Outcome Measures - Weight-for-height Z score [ Time Frame: At enrollment, at participant study completion (up until 7 years) ]
    Median and interquartile range, % of participants with Z scores corresponding to mild, moderate, or severe malnutrition

  4. Clinical Outcome Measures - Head circumference measured in cm [ Time Frame: At birth, 24 months of age ]
    Median and interquartile range; to characterize long-term clinical profile

  5. Clinical Outcome Measures - Head circumference-for-age Z score [ Time Frame: At birth, 24 months of age ]
    Median and interquartile range; to characterize long-term clinical profile

  6. Clinical Outcome Measures - Cumulative incidence of WHO clinical Stage 3 or Stage 4 conditions [ Time Frame: At enrollment, at participant study completion (up until 7 years) ]
    % of patients with outcome; to characterize long-term clinical profile

  7. Clinical Outcome Measures - Cumulative incidence of medical conditions that required hospitalization, resulted in persistent or significant disability or incapacity, were life threatening, or resulted in death [ Time Frame: At enrollment, at participant study completion (up until 7 years) ]
    % of patients with outcome; to characterize long-term clinical profile

  8. Clinical Outcome Measures - Cumulative incidence of other medical conditions of interest [ Time Frame: At enrollment, at participant study completion (up until 7 years) ]
    % of patients with outcome; to characterize long-term clinical profile

  9. Clinical Outcome Measures - Cumulative incidence of mortality [ Time Frame: At study participant completion (up until 7 years) ]
    % of patients with outcome; to characterize long-term clinical profile

  10. Immunologic Outcome Measures - CD4+ cell counts and percentages [ Time Frame: At enrollment, at participant study completion (up until 7 years) ]
    Median and interquartile range; to characterize long-term immunologic profile

  11. Immunologic Outcome Measures - CD8+ cell counts and percentages [ Time Frame: At enrollment, at participant study completion (up until 7 years) ]
    Median and interquartile range; to characterize long-term immunologic profile

  12. Immunologic Outcome Measures - HIV-1 antibody status [ Time Frame: At enrollment, at participant study completion (up until 7 years) ]
    % of participants with negative serostatus

  13. Virologic Outcome Measures - HIV-1 RNA in plasma [ Time Frame: At enrollment, at participant study completion (up until 7 years) ]
    % of participants with HIV-1 RNA below the limit of detection of the assay among participants with quantifiable HIV-1 RNA, median and interquartile range

  14. Virologic Outcome Measures - HIV-1 DNA concentration in PBMCs [ Time Frame: At enrollment, at participant study completion (up until 7 years) ]
    % of participants with HIV-1 DNA below the limit of detection of the assay among participants with quantifiable HIV-1 DNA, median and interquartile range

  15. Virologic Outcome Measures - HIV-1 ARV resistance mutations [ Time Frame: At enrollment, at participant study completion (up until 7 years) ]
    % of participants with resistance mutations


Biospecimen Retention:   Samples With DNA
The following specimens will be collected: HIV-1 RNA PCR, HIV-1 DNA ddPCR, CD4+ and CD8+ cell counts and percentages, HIV-1 antibody, Serum, plasma, and peripheral blood mononuclear cell (PBMC) storage, ARV resistance testing if clinically indicated. If child is three years of age or older, collect nasopharyngeal and rectal swabs for storage.


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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Up to approximately 250 children living with HIV who received early treatment in IMPAACT network studies or other research studies sponsored by the US National Institutes of Health (NIH)
Criteria

Inclusion Criteria:

  • Participated in one of the parent studies
  • Confirmed HIV-1 infection based on documented nucleic acid testing of two blood samples collected at different time points
  • Received early treatment for HIV-1 infection, defined as treatment with at least three ARV agents from at least two classes of ART, initiated within 12 weeks of birth
  • Based on parent or guardian report at entry, child is expected to be available for at least 24 months of follow-up
  • Parent or guardian is willing and able to provide written informed consent for child's study participation and, when applicable per institutional review board/ethics committee (IRB/EC) policies and procedures, child is willing and able to provide written assent for study participation

Exclusion Criteria:

  • Has any documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe or otherwise interfere with completing study procedures

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): NCT05154513


Contacts
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Contact: Anne Coletti, MS 919.544.7040 acoletti@fhi360.org
Contact: Shaun Barnabas, MD, PhD 27-21-938-4153 barnabas@sun.ac.za

Locations
Show Show 33 study locations
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)
National Institute of Mental Health (NIMH)
Investigators
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Study Chair: Shaun Barnabas, MD, PhD University of Stellenbosch
Study Chair: Samantha Fry, MD, MMed University of Stellenbosch
Study Chair: Julia Rosebush, DO, FAAP University of Chicago
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Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT05154513    
Other Study ID Numbers: IMPAACT 2028
UM1AI068632 ( U.S. NIH Grant/Contract )
UM1AI068616 ( U.S. NIH Grant/Contract )
UM1AI106716 ( U.S. NIH Grant/Contract )
HHSN275201800001I ( Other Grant/Funding Number: Eunice Kennedy Shriver National Institute of Child Health and Human Development )
First Posted: December 13, 2021    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie results in the publication, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
Access Criteria:
  • With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.
  • For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network.
  • By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases