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A Phase I Study to Evaluate the Immunologic Response and Virologic Impact of AGS-004

NCT02042248 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-05-04

No results posted yet for this study

Summary

The purpose of this study is to:

* find out the intensity and duration of the immune response after multiple injections of the investigational study product AGS-004 made from one's own dendritic cells and one's own strain of HIV;
* understand the changes in the body's HIV DNA , and HIV-1 RNA in peripheral and resting CD4+ cells prior to and following administration of AGS- 004.
* find out if low levels of HIV virus that are not detectable by standard HIV RNA assays will decrease following the administration of AGS-004.
* find out if it is safe to give individuals with HIV multiple injections of AGS-004 made from the person's own dendritic cells and their own strain of HIV.
* find out if administration of AGS-004 decreases the amount of latent HIV infection in resting CD4 cells

Conditions

Interventions

BIOLOGICAL

AGS-004

All participants in both arms will receive the same treatment and doses of AGS-004 in Step 2 at weeks 0, 4, 8, and 12.

Sponsors & Collaborators

  • Argos Therapeutics

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Cynthia L Gay, MD

    lead OTHER

Principal Investigators

  • Cynthia Gay, MD, MPH · University of North Carolina

  • David Margolis, MD · University of North Carolina

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02042248 on ClinicalTrials.gov