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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05154513
Other study ID # IMPAACT 2028
Secondary ID UM1AI068632UM1AI
Status Recruiting
Phase
First received
Last updated
Start date February 2, 2022
Est. completion date November 30, 2027

Study information

Verified date March 2024
Source International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Contact Anne Coletti, MS
Phone 919.544.7040
Email acoletti@fhi360.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date November 30, 2027
Est. primary completion date November 30, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cohort 1
No intervention provided in this study

Locations

Country Name City State
Botswana Gaborone CRS 12701 Gaborone
Botswana Molepolole Prevention/Treatment Trials CRS 12702 Molepolole
Brazil School of Medicine, University of Minas Gerais - FUNDEP (5073) Belo Horizonte
Brazil 5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site Rio De Janeiro
Brazil Hospital dos Servidores Rio de Janeiro Rio De Janeiro
Brazil Hospital Geral De Nova Igaucu (5097) Rio de Janeiro
Brazil Ribeirao Preto Medical School, University of Sao Paulo (5074) Sao Paulo
Haiti Les Centres GHESKIO (30022) Port-au-Prince
Kenya 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center Kericho Clinical Research Site Kericho
Malawi College of Med. JHU CRS (30301) Blantyre
Malawi University of North Carolina Lilongwe (12001) Lilongwe
South Africa 30300, Umlazi Clinical Research Site Durban
South Africa 8051, Wits RHI Shandukani Research Centre Clinical Research Site Johannesburg
South Africa Soweto IMPAACT CRS (8052) Johannesburg Gauteng
South Africa Family Clinical Research Unit (FAM-CRU) CRS (8950) Tygerberg Hills
Tanzania Kilimanjaro Christian Medical Centre (5118) Moshi
Thailand Siriraj Hospital Mahidol University CRS (5115) Bangkok Ratchathewi
Thailand Chiang Rai Regional Hospital (5116) Chiang Rai
Uganda 31798, Baylor-Uganda Clinical Research Site Kampala
United States 5030, Emory University School of Medicine Clinical Research Site Atlanta Georgia
United States University of Colorado (5052) Aurora Colorado
United States Johns Hopkins University NICHD CRS (5092) Baltimore Maryland
United States Bronx-Lebanon Hospital Center (CRS 5114) Bronx New York
United States 5055, South Florida CDTC Fort Lauderdale Clinical Research Site Fort Lauderdale Florida
United States 5128, Texas Children's Hospital Clinical Research Site Houston Texas
United States University of Florida (5051) Jacksonville Florida
United States 32017, Children's Mercy Hospital Clinical Research Site Kansas City Missouri
United States David Geffen School of Medicine at UCLA (CRS 5112) Los Angeles California
United States St. Jude Childrens Research Hosp, Memphis (6501) Memphis Tennessee
United States Univ of Miami Pediatric/Perinatal HIV/AIDS (5127) Miami Florida
United States University California, San Diego (CRS 4601) San Diego California
Zimbabwe Seke North CRS 30306 Chitungwiza
Zimbabwe St. Mary's CRS 30303 Chitungwiza
Zimbabwe Harare Family Care (31890) Harare

Sponsors (4)

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

Countries where clinical trial is conducted

United States,  Zimbabwe,  Botswana,  Brazil,  Haiti,  Kenya,  Malawi,  South Africa,  Tanzania,  Thailand,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Outcome Measures - Weight measured in kg Median and interquartile range; to characterize long-term clinical profile At enrollment, at participant study completion (up until 7 years)
Primary Clinical Outcome Measures - Height measured in cm Median and interquartile range; to characterize long-term clinical profile At enrollment, at participant study completion (up until 7 years)
Primary Clinical Outcome Measures - Weight-for-height Z score Median and interquartile range, % of participants with Z scores corresponding to mild, moderate, or severe malnutrition At enrollment, at participant study completion (up until 7 years)
Primary Clinical Outcome Measures - Head circumference measured in cm Median and interquartile range; to characterize long-term clinical profile At birth, 24 months of age
Primary Clinical Outcome Measures - Head circumference-for-age Z score Median and interquartile range; to characterize long-term clinical profile At birth, 24 months of age
Primary Clinical Outcome Measures - Cumulative incidence of WHO clinical Stage 3 or Stage 4 conditions % of patients with outcome; to characterize long-term clinical profile At enrollment, at participant study completion (up until 7 years)
Primary 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 % of patients with outcome; to characterize long-term clinical profile At enrollment, at participant study completion (up until 7 years)
Primary Clinical Outcome Measures - Cumulative incidence of other medical conditions of interest % of patients with outcome; to characterize long-term clinical profile At enrollment, at participant study completion (up until 7 years)
Primary Clinical Outcome Measures - Cumulative incidence of mortality % of patients with outcome; to characterize long-term clinical profile At study participant completion (up until 7 years)
Primary Immunologic Outcome Measures - CD4+ cell counts and percentages Median and interquartile range; to characterize long-term immunologic profile At enrollment, at participant study completion (up until 7 years)
Primary Immunologic Outcome Measures - CD8+ cell counts and percentages Median and interquartile range; to characterize long-term immunologic profile At enrollment, at participant study completion (up until 7 years)
Primary Immunologic Outcome Measures - HIV-1 antibody status % of participants with negative serostatus At enrollment, at participant study completion (up until 7 years)
Primary Virologic Outcome Measures - HIV-1 RNA in plasma % 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 At enrollment, at participant study completion (up until 7 years)
Primary Virologic Outcome Measures - HIV-1 DNA concentration in PBMCs % 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 At enrollment, at participant study completion (up until 7 years)
Primary Virologic Outcome Measures - HIV-1 ARV resistance mutations % of participants with resistance mutations At enrollment, at participant study completion (up until 7 years)
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