163 Participants Needed

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

Recruiting at 31 trial locations
SB
AC
Overseen ByAnne Coletti, MS
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Must be taking: ARV agents
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

SB

Shaun Barnabas, MD, PhD

Principal Investigator

University of Stellenbosch

SF

Samantha Fry, MD, MMed

Principal Investigator

University of Stellenbosch

JR

Julia Rosebush, DO, FAAP

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Participants are enrolled in the study and baseline measurements are taken

At enrollment
1 visit (in-person)

Observational Follow-up

Participants are followed semi-annually for clinical, virologic, and immunologic evaluations

Up to 7 years
Semi-annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • NA
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Cohort 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Lead Sponsor

Trials
35
Recruited
11,900+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+
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