Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02411539 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 13
- Study locations
NCT02411539: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02411539 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 40 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (91% lower). The trial reports 13 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02411539, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 13
- Study locations
Study Summary
The purpose of this study was to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults infected with HIV who were receiving antiretroviral therapy (ART).
Primary Outcome
Refer to detailed description in the protocol section. Includes signs/symptoms, lab toxicities, and/or clinical events that are possibly, probably, or definitely related to study treatment (as judged by the core team, blinded to treatment arm) at any time from the initial dose of VRC01 to end of study follow-up. This analysis was primarily descriptive and no significance testing was performed.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL VRC01
Study Locations (13)
California
- UCSD Antiviral Research Center CRS - San Diego
Colorado
- University of Colorado Hospital CRS - Aurora
Illinois
- Northwestern University CRS - Chicago
Maryland
- Johns Hopkins University CRS - Baltimore
Massachusetts
- Massachusetts General Hospital CRS (MGH CRS) - Boston
Missouri
- Washington University Therapeutics (WT) CRS - St Louis
New York
- University of Rochester Adult HIV Therapeutic Strategies Network CRS - Rochester
North Carolina
- Chapel Hill CRS - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-08-25 |
| Est. Completion | 2016-09-29 |
| Phase | Phase 1 |
What the finished NCT02411539 record still lists
NCT02411539 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (91% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02411539 lists 13 locations in 13 states (California, Colorado, Illinois).
Frequently Asked Questions
What is clinical trial NCT02411539 about?
NCT02411539 is a clinical study titled "Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)". The purpose of this study was to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults infected with HIV who were receiving antiretroviral therapy (ART).
What is the current status of trial NCT02411539?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2015-08-25. Estimated completion is 2016-09-29.
What conditions does trial NCT02411539 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT02411539?
The interventions under investigation include: Placebo (BIOLOGICAL), VRC01 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02411539?
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 NCT02411539 being conducted?
This trial has 13 study locations across California, Colorado, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
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 NCT02411539's enrollment target sits among peer trials
40 390th of 542 higher than 139 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
CAR-T Cells for HIV Infection
RECRUITING · Phase 1
-
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
RECRUITING · Phase 1
-
Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706
RECRUITING · Phase 1
-
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
RECRUITING · Phase 1
-
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
RECRUITING · Phase 1
-
First Time in Human Study of Long Acting VH4524184 Formulations
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI