Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
- Conditions
- HIV Infection
- Registration Number
- NCT05154513
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Outcome Measures - Height measured in cm At enrollment, at participant study completion (up until 7 years) Median and interquartile range; to characterize long-term clinical profile
Clinical Outcome Measures - Weight-for-height Z score 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
Clinical Outcome Measures - Cumulative incidence of other medical conditions of interest At enrollment, at participant study completion (up until 7 years) % of patients with outcome; to characterize long-term clinical profile
Clinical Outcome Measures - Weight measured in kg At enrollment, at participant study completion (up until 7 years) Median and interquartile range; to characterize long-term clinical profile
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 At enrollment, at participant study completion (up until 7 years) % of patients with outcome; to characterize long-term clinical profile
Virologic Outcome Measures - HIV-1 DNA concentration in PBMCs 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
Clinical Outcome Measures - Head circumference measured in cm At birth, 24 months of age Median and interquartile range; to characterize long-term clinical profile
Immunologic Outcome Measures - CD8+ cell counts and percentages At enrollment, at participant study completion (up until 7 years) Median and interquartile range; to characterize long-term immunologic profile
Clinical Outcome Measures - Head circumference-for-age Z score At birth, 24 months of age Median and interquartile range; to characterize long-term clinical profile
Clinical Outcome Measures - Cumulative incidence of mortality At study participant completion (up until 7 years) % of patients with outcome; to characterize long-term clinical profile
Immunologic Outcome Measures - CD4+ cell counts and percentages At enrollment, at participant study completion (up until 7 years) Median and interquartile range; to characterize long-term immunologic profile
Virologic Outcome Measures - HIV-1 RNA in plasma 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
Clinical Outcome Measures - Cumulative incidence of WHO clinical Stage 3 or Stage 4 conditions At enrollment, at participant study completion (up until 7 years) % of patients with outcome; to characterize long-term clinical profile
Virologic Outcome Measures - HIV-1 ARV resistance mutations At enrollment, at participant study completion (up until 7 years) % of participants with resistance mutations
Immunologic Outcome Measures - HIV-1 antibody status At enrollment, at participant study completion (up until 7 years) % of participants with negative serostatus
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
David Geffen School of Medicine at UCLA (CRS 5112)
🇺🇸Los Angeles, California, United States
University of Colorado (5052)
🇺🇸Aurora, Colorado, United States
5055, South Florida CDTC Fort Lauderdale Clinical Research Site
🇺🇸Fort Lauderdale, Florida, United States
Univ of Miami Pediatric/Perinatal HIV/AIDS (5127)
🇺🇸Miami, Florida, United States
5030, Emory University School of Medicine Clinical Research Site
🇺🇸Atlanta, Georgia, United States
5128, Texas Children's Hospital Clinical Research Site
🇺🇸Houston, Texas, United States
Gaborone CRS 12701
🇧🇼Gaborone, Botswana
Molepolole Prevention/Treatment Trials CRS 12702
🇧🇼Molepolole, Botswana
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
Scroll for more (18 remaining)David Geffen School of Medicine at UCLA (CRS 5112)🇺🇸Los Angeles, California, United States