Intensive Antiretroviral Therapy for HIV/AIDS in Infants
What You Need to Know Before You Apply
What is the purpose of this trial?
The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.
Is Raltegravir safe for use in humans, including infants?
Raltegravir has been shown to be well tolerated in adults, children, and adolescents with HIV-1 infection, and it is considered safe with milder side effects compared to other treatments. It is also used in neonates and young infants, although specific safety data for this age group is limited.12345
What makes this drug unique for treating HIV/AIDS in infants?
What data supports the effectiveness of the drug Raltegravir for treating HIV/AIDS in infants?
Raltegravir has been shown to be effective in reducing HIV levels in both adults and children, and it has been used successfully in newborns with high levels of the virus, significantly lowering the virus count within a month. It is well tolerated in infants, making it a promising option for treating HIV in this age group.12378
Who Is on the Research Team?
Ellen Chadwick, MD
Principal Investigator
Northwestern University Feinberg School of Medicine and Ann & Robert Lurie Children's Hospital of Chicago
Jennifer Jao, MD
Principal Investigator
Northwestern University Feinberg School of Medicine and Ann & Robert Lurie Children's Hospital of Chicago
Are You a Good Fit for This Trial?
This trial is for HIV-infected infants born to mothers with confirmed or presumed HIV. Infants must be less than 48 hours old, at least 36 weeks gestational age, weigh over 2 kg, and able to take oral medication. Mothers should not have received antiretrovirals during pregnancy but may have during labor.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Early Intensive Treatment
Infants receive early intensive antiretroviral therapy (ART) within 48 hours of birth
Analytic Treatment Interruption (ATI)
Children who meet criteria interrupt ART and are monitored for viral rebound
Re-initiation of ART
Children who experience viral rebound or meet other criteria re-initiate ART and are monitored for re-suppression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lopinavir/Ritonavir
- Nevirapine
- Nucleoside Reverse Transcriptase Inhibitors
- Raltegravir
- VRC01
Lopinavir/Ritonavir is already approved in United States, European Union for the following indications:
- HIV Infection
- Nonoccupational Exposure
- HIV Infection
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator