RecruitingPhase 1/2

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

United States1,120 participantsStarted 2015-01-23

Plain-language summary

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.

Who can participate

Age range48 Hours

SexALL

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Inclusion criteria

✓. Presumed or confirmed maternal HIV infection:
✓. Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with IRB/EC policies and procedures. Otherwise, informed consent must be obtained from a legal guardian and the mother must provide written assent.
✓. Was not previously enrolled in this study with another infant.
✓. Did not receive ARVs during the current pregnancy.
✓. Infant is eligible per inclusion criteria.
✓. Less than or equal to 48 hours of age.
✓. Greater than or equal to 37 weeks gestational age at birth (assessment of gestational age will be based on the best clinical estimate determined by date of last menstrual period, antenatal ultrasound, fundal height, or Ballard Score).
✓. Greater than or equal to 2 kilograms (kg) at birth.

What they're measuring

Number of participants who achieve HIV remission

Timeframe: Measured through Week 48

Trial details

NCT IDNCT02140255

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2028-01-31

Contact for this trial

Anne Coletti, MS

919-627-6445 acoletti@fhi360.org

View on ClinicalTrials.gov More HIV Infection trials