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NCT05154513

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

International Maternal Pediatric Adolescent AIDS Clinical Trials Group·ClinicalTrials.gov·otherRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
HIV Infection
Drug/Device/Intervention
Cohort 1
Study type
Observational
Intervention type
other
Sponsor & location
Primary sponsor
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Location
Los Angeles,San Diego,Aurora,Fort Lauderdale,Jacksonville,Miami,Atlanta,Baltimore,Kansas City,Bronx,Memphis,Houston,Gaborone,Molepolole,Belo Horizonte,Rio De Janeiro,Rio de Janeiro,Sao Paulo,Port-au-P, Botswana,Brazil,Haiti,Kenya,Malawi,South Africa,Tanzania,Thailand,Uganda,United States of America,Zi
Timeline & enrollment
Phase
N/A
Start date
Feb 02, 2022
End date
Nov 30, 2027
Enrollment
250 participants
Primary outcome

Clinical Outcome Measures - Weight measured in kg,Clinical Outcome Measures - Height measured in cm,Clinical Outcome Measures - Weight-for-height Z score,Clinical Outcome Measures - Head circumference measured in cm,Clinical Outcome Measures - Head circumference-for-age Z score,Clinical Outcome Measures - Cumulative incidence of WHO clinical Stage 3 or Stage 4 conditions,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,Clinical Outcome Measures - Cumulative incidence of other medical conditions of interest,Clinical Outcome Measures - Cumulative incidence of mortality,Immunologic Outcome Measures - CD4+ cell counts and percentages,Immunologic Outcome Measures - CD8+ cell counts and percentages,Immunologic Outcome Measures - HIV-1 antibody status,Virologic Outcome Measures - HIV-1 RNA in plasma,Virologic Outcome Measures - HIV-1 DNA concentration in PBMCs,Virologic Outcome Measures - HIV-1 ARV resistance mutations

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.

ICD-10 classifications
HIV disease resulting in other viral infectionsHuman immunodeficiency virus [HIV] diseaseHIV disease resulting in other bacterial infectionsAcute HIV infection syndromeUnspecified human immunodeficiency virus [HIV] disease
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05154513
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05154513 through Pure Global AI's free database. This phase not specified trial is sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group and is currently Recruiting. The study focuses on HIV Infection. Target enrollment is 250 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.