NCT02140255 · National Institute of Allergy and Infectious Diseases (NIAID)
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Chosen by the site investigator and dosed according to World Health Organization (WHO) or individual country or local standard guidelines.
DRUG
Nevirapine (NVP)
Administered orally. Dosed according to study step/participant's age/participant's weight.
DRUG
Lopinavir/Ritonavir (LPV/r)
Administered orally. Dosed according to study step and participant's age.
DRUG
Raltegravir (RAL)
Administered orally. Dosed according to study step and participant's age.
DRUG
VRC01
40 mg/kg administered subcutaneously.
DRUG
Dolutegravir (DTG)
Dosed according to study step/participant's age/participant's weight
DRUG
VRC07-523LS
40 mg/kg administered subcutaneously.
Primary outcome measures
Number of participants who achieve HIV remission
Time frame: Measured through Week 48
Defined as no confirmed HIV RNA greater than or equal to the limit of detection (LOD) through 48 weeks of treatment interruption
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Presumed or confirmed maternal HIV infection:
- Mothers will be eligible to enroll with EITHER:
- Presumed HIV infection defined as at least one positive rapid HIV antibody-based test result from a sample collected in the peripartum period. Presumed infection must be confirmed within 10 business days of enrollment OR
- Confirmed HIV infection defined as positive results from two samples collected at different timepoints 2. 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. 3. Was not previously enrolled in this study with another infant. 4. Did not receive ARVs during the current pregnancy
Where
- La Jolla, California
- Los Angeles, California
- Aurora, Colorado
- Fort Lauderdale, Florida
- Jacksonville, Florida
- Miami, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Baltimore, Maryland
- Boston, Massachusetts
- Stony Brook, New York
- The Bronx, New York
And 4 more locations — see the full list below.
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations