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NCT01993706 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults
A Phase 1 study of HIV Infection and Monoclonal Antibody, Human, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT01993706 is a Phase 1 study of HIV Infection and Monoclonal Antibody, Human that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 29 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01993706, a Phase 1 study of HIV Infection and Monoclonal Antibody, Human, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- VRC01 is a manmade antibody directed against the human immunodeficiency virus (HIV). Antibodies fight infection. Researchers eventually want to know if VRC01 helps prevent or treat HIV infection. In this study they want to know if the study drug is safe if taken in a vein or under the skin. Taking VRC01 in this study will not protect against HIV infection. Objectives: \- To see if VRC01 and placebo are safe and well tolerated. Eligibility: \- Healthy adults 18 to 50 years old. Design: * Participants will be screened with medical history, physical exam, and lab tests. * Participants will be randomly divided into 4 groups. VRC01 or the placebo will be given in weeks 1 and 4. Blood samples will be taken several times after each VRC01 or placebo dose. * Three groups will receive VRC01 by needle into a vein with an IV pump. It will take about 1 hour and it is done in the hospital. * One group will receive either VRC01 or the placebo by needle into the fatty tissue under the skin, usually the belly. It will take up to 20 minutes and it is done in the hospital. * Participants will stay in the hospital overnight after receiving the medication and have about 14 clinic visits over 4 months. Most clinic visits last about 2 hours. * Participants will keep a symptom diary after receiving the medicatino. * Participants can volunteer to have mouth, rectal, and genital samples taken throughout the study. * The study will last 8 months.
Conditions Studied
Interventions
- DRUG VRC-HIVMAB060-00-AB
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2013-11-19 |
| Est. Completion | 2015-02-27 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01993706
The ClinicalTrials.gov registry entry for NCT01993706 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (88% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with HIV Infection appearing as the primary indexed condition, and to 1 intervention - of which VRC-HIVMAB060-00-AB is the first listed.
NCT01993706 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01993706 about?
NCT01993706 is a clinical study titled "Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults". Background: \- VRC01 is a manmade antibody directed against the human immunodeficiency virus (HIV). Antibodies fight infection. Researchers eventually want to know if VRC01 helps prevent or treat HIV infection. In this study they want to know if the study drug is safe if taken in a vein or under th...
What is the current status of trial NCT01993706?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2013-11-19. Estimated completion is 2015-02-27.
What conditions does trial NCT01993706 study?
This clinical trial studies the following conditions: HIV Infection, Monoclonal Antibody, Human, HIV Antibodies, VRC01 Monoclonal Antibody, Neutralizing Antibody.
What interventions are being tested in trial NCT01993706?
The interventions under investigation include: VRC-HIVMAB060-00-AB (DRUG).
Who is sponsoring clinical trial NCT01993706?
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 NCT01993706 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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