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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05154513
• Other study ID #: IMPAACT 2028
• Secondary ID: UM1AI068632UM1AI
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

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)