Principal Investigator
Enrollment Status
Clinical Trial ID
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.
Phase
N/A
Funding Agency/Sponsor
Other
Disease
HIV-related
Enrollment 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