Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy
NCT ID: NCT03208231
Last Updated: 2023-05-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
61 participants
INTERVENTIONAL
2018-08-06
2021-02-11
Brief Summary
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Detailed Description
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All infants were required to have initiated cART within 14 days before or at study entry. Infants were randomly assigned to either receive VRC01 (VRC01, Arm 1) or not receive VRC01 (No-VRC01, Arm 2). Randomization was stratified by whether the initial cART regimen included an integrase inhibitor.
Infants in the VRC01 arm received VRC01 injections at study entry (Week 0) and Weeks 2, 6, and 10. Infants in the No-VRC01 arm received no study product.
Infants attended study visits at Weeks 1, 2, 3, 6, 7, 10, 11, 14, 16, 20, 24, 36, and 48. Visits included physical examinations, blood and urine collection.
Infants' mothers could optionally be enrolled in the study for one-time specimen collection for exploratory evaluations. Maternal study participation was not required for infant study participation.
The study was closed to enrollment prematurely on March 19, 2020 due to the outbreak of coronavirus disease 2019 (COVID-19) and after enrolling 61 of the targeted 68 infants.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VRC01 (Arm 1)
Infants received VRC01 subcutaneous injections (40 mg/kg) at Weeks 0, 2, 6, and 10.
VRC01
40 mg/kg of VRC01 administered by subcutaneous injection.
Combination Antiretroviral Therapy (cART)
All infants received non-study provided cART selected by their primary care provider and supplied through non-study sources (i.e., cART not provided through the study).
No-VRC01 (Arm 2)
Infants did not receive VRC01.
Combination Antiretroviral Therapy (cART)
All infants received non-study provided cART selected by their primary care provider and supplied through non-study sources (i.e., cART not provided through the study).
Interventions
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VRC01
40 mg/kg of VRC01 administered by subcutaneous injection.
Combination Antiretroviral Therapy (cART)
All infants received non-study provided cART selected by their primary care provider and supplied through non-study sources (i.e., cART not provided through the study).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed HIV-1 infection
* The following laboratory values at screening:
* Cluster of differentiation 4 (CD4) lymphocyte percentage greater than 15
* Severity grade 1 or lower hemoglobin, platelet count, and absolute neutrophil count
* Severity grade 1 or lower alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase
* First dose of initial combination antiretroviral therapy (cART) regimen taken on the day of randomization or within 14 days prior to the day of randomization
* Expected to be available for 48 weeks of follow-up at study entry
* Parent or legal guardian willing and able to provide written informed consent for infant participation in the study
* Parent or legal guardian willing and able to complete reactogenicity memory aids for study purposes, based on parent/guardian report.
The mothers of enrolled infants were asked to consent to blood collection and storage for this study. The following criteria must have been met in order for mothers to undergo blood collection for this purpose:
* Mother was willing and able to provide independent written informed consent for blood collection and storage for virology and immunology investigations
* Mother had no documented or suspected condition that, in the opinion of the site investigator or designee, would make blood collection unsafe
Exclusion Criteria
* Initiated a combination of three or more antiretrovirals, all at or above recommended treatment doses, within 48 hours of birth
* Received within 30 days prior to study entry, or was identified as requiring, any of the following:
* Chronic (more than 14 days) systemic steroid treatment
* Immunoglobulin treatment
* Immunomodulators (interleukins, interferons, cyclosporin)
* Cytotoxic chemotherapy
* Treatment for active tuberculosis (TB) disease
* Any investigational agent
* Note: Treatment for latent TB infection was permitted
* Any documented or suspected clinically significant medical illness, clinically significant congenital anomaly, or immediately life-threatening condition that, in the opinion of the site investigator or designee, would interfere with the infant's ability to comply with study requirements
* Any other condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
0 Weeks
12 Weeks
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Elizabeth (Betsy) McFarland, MD
Role: STUDY_CHAIR
University of Colorado School of Medicine
Alka Khaitan, MD
Role: STUDY_CHAIR
Indiana University School of Medicine
Locations
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Molepolole CRS
Molepolole, Kweneng District, Botswana
Gaborone CRS
Gaborone, South-East District, Botswana
Hosp. Geral De Nova Igaucu Brazil NICHD CRS
Rio de Janeiro, , Brazil
Hospital Federal dos Servidores do Estado NICHD CRS
Rio de Janeiro, , Brazil
Malawi CRS
Lilongwe, Central Region, Malawi
Blantyre CRS
Blantyre, , Malawi
Harare Family Care CRS
Harare, , Zimbabwe
Countries
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References
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Khaitan A, Lindsey J, Capparelli E, Tierney C, Coletti A, Perlowski C, Cotton MF, Yin DE, Majji S, Moye J, Spiegel H, Harding P, Costello D, Krotje C, Gama L, Persaud D, McFarland EJ, on behalf of the IMPAACT 2008 Protocol Team. Phase I/II Study of monoclonal antibody VRC01 with early antiretroviral therapy to promote clearance of HIV-1 infected cells in infants (IMPAACT 2008). Oral presentation at 24th International AIDS Conference, July 2022.
Provided Documents
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Document Type: Study Protocol: Protocol Version 2.0
Document Type: Study Protocol: Letter of Amendment 1.0
Document Type: Study Protocol: Letter of Amendment 2.0
Document Type: Study Protocol: Protocol Clarification Memo 1.0
Document Type: Study Protocol: Protocol Clarification Memo 2.0
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (AE) Grading Table, Corrected Version 2.1, dated July 2017.
Manual for Expedited Reporting of Adverse Events (EAE) to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010
Other Identifiers
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20735
Identifier Type: REGISTRY
Identifier Source: secondary_id
IMPAACT 2008
Identifier Type: -
Identifier Source: org_study_id
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