Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-21 @ 10:58 PM
Study NCT ID:
NCT02591420
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2015-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
Safety and Virologic Effect of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), With Broad HIV-1 Neutralizing Activity, Administered Intravenously to Adults During Early Acute HIV Infection
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the safety and virologic effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral therapy (ART), in adults during early acute HIV infection.
Detailed Description:
Human monoclonal antibodies (mAbs) may have the potential to treat HIV infection by preventing the spread of the virus. This study will evaluate an experimental mAB known as VRC-HIVMAB060-00-AB (VRC01). The purpose of this study is to evaluate the safety and virologic effect of VRC01, alone or in combination with ART, in adults with early acute HIV infection. Researchers will also evaluate the effect of VRC01 on the establishment of an HIV reservoir during early acute HIV infection.
This study will enroll participants who are diagnosed with early acute HIV infection. Participants will be randomly assigned to one of three groups: Group 1 will begin ART and receive a single infusion of placebo at Day 0. Group 2 will begin ART and receive a single infusion of VRC01 at Day 0. Group 3 will receive a single infusion of VRC01 on Day 0 and begin ART on Day 7. ART will vary by country and will consist of country guideline-recommended, available first line combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Study visits will occur at Days 0, 1, 3, 7, 10, 14, 18, 21, 25, 28, 42, 56, 84, 112, 168, and 175. Visits will include a physical examination, medical history review, and blood collection. Neurocognitive testing will take place on Day 168. Some participants may take part in optional study procedures at various time points during the study including mucosal secretion collection, rectosigmoid biopsy, lymph node biopsy, leukapheresis, and lumbar puncture.
This study will enroll participants who are diagnosed with early acute HIV infection. Participants will be randomly assigned to one of three groups: Group 1 will begin ART and receive a single infusion of placebo at Day 0. Group 2 will begin ART and receive a single infusion of VRC01 at Day 0. Group 3 will receive a single infusion of VRC01 on Day 0 and begin ART on Day 7. ART will vary by country and will consist of country guideline-recommended, available first line combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Study visits will occur at Days 0, 1, 3, 7, 10, 14, 18, 21, 25, 28, 42, 56, 84, 112, 168, and 175. Visits will include a physical examination, medical history review, and blood collection. Neurocognitive testing will take place on Day 168. Some participants may take part in optional study procedures at various time points during the study including mucosal secretion collection, rectosigmoid biopsy, lymph node biopsy, leukapheresis, and lumbar puncture.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: