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NCT04408963 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
A Phase 1 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04408963: Completed Phase 1 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04408963 is a Phase 1 study of HIV that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04408963, a Phase 1 study of HIV, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs. Researchers want to test an antibody, CAP256V2LS. Objective: To test CAP256V2LS to see if it is safe and how the body responds to it. Eligibility: Healthy people, ages 18-60 Design: Participants were screened with a medical history, physical exam, and blood tests. Some females had a pregnancy test. Participants were assigned to one of two groups. Based on their group, they got 1 dose of CAP256V2LS in 1 of 2 ways: * Some participants got CAP256V2LS as an infusion. A thin tube was placed in an arm vein and CAP256V2LS was given into the vein using a pump. * Some participants got CAP256V2LS injected under the skin. A small needle was used to inject CAP256V2LS into the fatty tissue of the belly, arm, or thigh. They got 1 to 4 injections. On the day they got CAP256V2LS, participants gave blood samples at different time points. Participants were asked to check their temperature every day for 7 days after receiving CAP256V2LS. They used a tool to measure any redness, swelling, or bruising they may have at the site where they received the study drug. Participants had visits at least 2-3 times during the first week after they got CAP256V2LS. Then they had about 9 more visits over the next 6 months. Visits included blood tests.
Primary Outcome
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogen
Conditions Studied
Interventions
- BIOLOGICAL VRC-HIVMAB0102-00-AB
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-03-22 |
| Est. Completion | 2022-11-28 |
| Phase | Phase 1 |
What the finished NCT04408963 record still lists
NCT04408963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (98% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 1 intervention - of which VRC-HIVMAB0102-00-AB is the first listed.
NCT04408963 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04408963 about?
NCT04408963 is a clinical study titled "A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults". Background: HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs. Researchers want to test an antibody, CAP256V2LS. Objective: To test CAP256V2LS to see if it is safe and how ...
What is the current status of trial NCT04408963?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2022-03-22. Estimated completion is 2022-11-28.
What conditions does trial NCT04408963 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT04408963?
The interventions under investigation include: VRC-HIVMAB0102-00-AB (BIOLOGICAL).
Who is sponsoring clinical trial NCT04408963?
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 NCT04408963 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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