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NCT02140255 · ClinicalTrials.gov registry record · Phase 1
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
A Phase 1 study of HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 1,120
- Enrollment target
- 20
- Study locations
NCT02140255: Recruiting Phase 1 study of HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02140255 is a Phase 1 study of HIV Infection that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,120 participants, above the 227-participant average among 73 other HIV Infection trials with a reported enrollment target (393% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02140255, a Phase 1 study of HIV Infection, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 1,120 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Defined as no confirmed HIV RNA greater than or equal to the limit of detection (LOD) through 48 weeks of treatment interruption
Conditions Studied
Interventions
- DRUG Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
- DRUG Nevirapine (NVP)
- DRUG Lopinavir/Ritonavir (LPV/r)
- DRUG Raltegravir (RAL)
- DRUG VRC01
Study Locations (20)
Florida
- 5055, South Florida CDTC Fort Lauderdale Clinical Research Site - Fort Lauderdale
- 5051, University of Florida Center for HIV/AIDS Research, Education and Service (UF CARES) Clinical Research Site - Jacksonville
- 5127, Pediatric Perinatal HIV Clinical Research Site - Miami
- University of Miami CRS - Miami
California
- 4601, University of California, San Diego Clinical Research Site - La Jolla
- 5048, University of Southern California Clinical Research Site - Los Angeles
- 5112, David Geffen School of Medicine at UCLA Clinical Research Site - Los Angeles
New York
- 5040, SUNY Stony Brook Clinical Research Site - Stony Brook
- 5114, Bronx Lebanon Hospital Center Clinical Research Site - The Bronx
- 5013, Jacobi Medical Center Clinical Research Site - The Bronx
Illinois
- 5083, Rush University Cook County Hospital Clinical Research Site - Chicago
- 4001, Lurie Children's Hospital of Chicago Clinical Research Site - Chicago
Texas
- Texas Children's Hospital CRS - Houston
- 5128, Baylor College of Medicine/Texas Children's Hospital Clinical Research Site - Houston
Colorado
- 5052, University of Colorado, Denver Clinical Research Site - Aurora
Georgia
- Emory University School of Medicine NICHD CRS - Atlanta
Maryland
- 5092, Johns Hopkins Clinical Research Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,120 participants |
| Start Date | 2015-01-23 |
| Est. Completion | 2031-12-31 |
| Phase | Phase 1 |
What NCT02140255 shows while recruiting
NCT02140255 is an interventional study that assigns participants to a tested intervention. Its 1,120 participants enrollment target places it among the larger protocols in the corpus, above the 227-participant average among 73 other HIV Infection trials with a reported enrollment target (393% higher).
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 5 interventions - of which Nucleoside Reverse Transcriptase Inhibitors (NRTIs) is the first listed.
NCT02140255 names 20 study sites across 11 states, led by Florida, California, New York.
Frequently Asked Questions
What is clinical trial NCT02140255 about?
NCT02140255 is a clinical study titled "Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission". 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.
What is the current status of trial NCT02140255?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 1,120 participants. The study started on 2015-01-23. Estimated completion is 2031-12-31.
What conditions does trial NCT02140255 study?
This clinical trial studies the following conditions: HIV Infection.
What interventions are being tested in trial NCT02140255?
The interventions under investigation include: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (DRUG), Nevirapine (NVP) (DRUG), Lopinavir/Ritonavir (LPV/r) (DRUG), Raltegravir (RAL) (DRUG), VRC01 (DRUG).
Who is sponsoring clinical trial NCT02140255?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02140255 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02140255's enrollment target sits among peer trials
1,120 4th of 73 higher than 70 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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