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Clinical Trials

MainTitle

Safety and Efficacy Study of AGS-004 During Analytical Treatment Interruption

This study has been completed
Sponsor
Argos Therapeutics


Information provided by (Responsible Party)
Argos Therapeutics
ClinicalTrials.gov Identifier
NCT01069809

First received: February 16, 2010
Last updated: January 23, 2017
Last Verified: January 2017
History of Changes
Purpose

Purpose

The purpose of this study is to determine the safety and effectiveness of AGS-004, an immune therapy, for HIV-infected individuals. Safety and effectiveness will be tested while the individuals are both taking antiretroviral therapy (ART) medication and interrupting ART medication.

Condition Intervention Phase
HIV Infection

Biological : AGS-004
Biological : Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase 2B Study Testing the Efficacy and Safety of AGS-004 on Host Control of HIV Replication During Analytical Treatment Interruption

Further study details as provided by Argos Therapeutics:

Primary Outcome Measures

  • Compare the anti-HIV effects of AGS-004 versus Placebo as measured by new HIV Viral Load setpoint after a 12 week Analytical Treatment Interruption [ Time Frame: 38 weeks ]
Secondary Outcome Measures:
  • Evaluate AGS-004 versus Placebo for change in plasma HIV Viral Load levels from the value just before initiation of ART to the value at the end of the 12 week ATI. [ Time Frame: 38 weeks ]
  • Evaluate AGS-004 versus Placebo for change from Baseline in CD4 T-Cell absolute and percentage values at Week 26 and at the end of Step 4 (for subjects continuing ATI) [ Time Frame: 38 weeks (62 weeks for subjects continuing ATI in Step 4) ]
  • Evaluate AGS-004 versus Placebo for effects on HIV viral kinetics during the 12 week ATI, as measured my mean or median levels of plasma HIV Viral Load; assessed throughout and at the end of Step 4 (for subjects continuing ATI) [ Time Frame: 38 weeks (62 weeks for subjects continuing ATI in Step 4) ]
  • Evaluate AGS-004 versus Placebo for change from Baseline in TEAEs, clinical laboratory evaluations, and clinical assessments. [ Time Frame: 2 years ]
  • Evaluate AGS-004 versus Placebo for change in inflammatory markers over treatment period and ATI [ Time Frame: 38 Weeks (62 weeks for subjects continuing ATI in Step 4) ]
  • Study immunogenicity and mechanism of action by evaluating AGS-004 versus Placebo for change from Baseline in T-cell response. [ Time Frame: 2 years ]
  • Study immunogenicity and mechanism of action by evaluating AGS-004 versus Placebo for change from Baseline of the extent of viral evolution. [ Time Frame: 2 years ]
  • Study immunogenicity and mechanism of action by evaluating AGS-004 versus Placebo for change from Baseline in the chromosomally integrated viral reservoir. [ Time Frame: 2 years ]

Enrollment: 53
Study Start Date: July 2010
Study Completion Date: September 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: AGS-004
HIV-1 Immune Therapy
Biological: AGS-004

HIV-1 Immune Therapy

Placebo Comparator: Inactive Injection
Inactive Placebo Injection
Biological: Placebo

Inactive Placebo Injection

Detailed Description:

The purpose of this study is to determine the safety and effectiveness of AGS-004, an immune therapy, for HIV-infected individuals. Safety and effectiveness will be tested while the individuals are both taking antiretroviral therapy (ART) medication and interrupting ART medication

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 60 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  1. Males and females ≥ 18 to 60 years of age.
  2. HIV infection.
  3. Stable ART regimen for ≥ 3 months prior to Screening.
  4. HIV VL level ≤ 400 copies/mL for ≥ 2 months prior to Screening.
  5. HIV VL level ≤ 50 copies/mL at Screening.
  6. CD4+ T cell count ≥ 450 cells/mm3 at Screening.
  7. Pre-ART nadir CD4+ T cell counts ≥ 200 cells/mm³.
  8. Availability of an adequate sample of frozen plasma most recently collected (no more than 90 days and preferably within 30 days) before starting ART.
  9. Laboratory values within pre-defined limits at Screening and Eligibility.
  10. Negative serum pregnancy test at Screening and Eligibility for females with reproductive potential, and agreement of all subjects to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug.
  11. Able and willing to give adequate written informed consent, to communicate effectively with study personnel, and willing to be compliant with protocol requirements.

  • Exclusion Criteria:
  • HIV-2 antibody positive at Screening Visit.
  • Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody (if positive HCV antibody, HCV RNA must be negative).
  • Untreated syphilis infection (positive rapid plasma reagin [RPR]).
  • Changes in ART regimen due to virologic breakthrough.
  • History of lymph node irradiation or dissection.
  • Prior use of any HIV immunotherapy or vaccine within 9 months prior to Screening.
  • Prior participation in an AGS-004 clinical study.
  • Treatment interruption of ART for > 1 month since starting the ART from which the pre-ART plasma sample was drawn.
  • Any acute infection or medical illness within 14 days prior to Screening and throughout the pre-treatment evaluation phase (Step 1).
  • Initiation of ART during the acute HIV infection stage, if date of infection known (acute infection defined as < 6 months between date of HIV infection and ART start date).
  • Pregnancy or breast-feeding.
  • Receipt of any immune modulators or suppressors within 30 days prior to Screening and throughout the pre-treatment evaluation phase (Step 1).
  • Evidence of hepatic decompensation in cirrhotic subjects: history of ascites, hepatic encephalopathy, or bleeding esophageal varices, or screening laboratory results of any of the following:
    • International Normalized Ratio (INR) of ≥ 1.5 X upper limit of normal (ULN);
    • Serum albumin < 3.3 g/dL;
    • Serum total bilirubin > 1.8 X ULN, unless history of Gilbert's disease or deemed related to treatment with atazanavir.
  • History or other clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, recent myocardial infarction, significant arrhythmia) or clinically significant electrocardiogram (ECG) abnormalities.
  • History of moderate or severe renal impairment (i.e., persistent history of creatinine clearance < 50 mL/min) or any other renal disorder deemed clinically significant by the investigator.
  • Prior history of an acquired immunodeficiency syndrome (AIDS) defining condition.
  • History or other evidence of severe illness, malignancy, immunodeficiency other than HIV, or any other condition that would make the subject unsuitable for the study in the opinion of the investigator.
  • Known allergy or sensitivity to the components of the investigational immunotherapy.
  • Active drug or alcohol use or dependence that would interfere with adherence to study requirements in the opinion of the investigator.
  • Use of systemic corticosteroids and use of topical steroids over a total area exceeding 15 cm² within 30 days prior to Screening.
  • Any investigational antiretroviral agents or use of a CCR5 inhibitor at Screening.
  • Active autoimmune disease or condition.
  • Participation in another investigational clinical study within the previous 30 days or use of investigational agents.
  • Body weight less than 30 kg.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT01069809

    Locations

    United States, California
    UCDavis Research Office at CARES
    Sacramento, California, United States, 95811
    United States, New York
    Jacobi & North Central Bronx Hospitals
    Bronx, New York, United States, 10461
    United States, North Carolina
    AIDS Clinical Trials Unit
    Chapel Hill, North Carolina, United States, 27514
    Duke University Medical Center
    Durham, North Carolina, United States, 27710
    United States, Pennsylvania
    Division of Infectious Disease and HIV Medicine Partnership Comprehensive Care Practice
    Philadelphia, Pennsylvania, United States, 191002
    Canada
    The Ottawa Hospital
    Ottawa, Ontario, Canada, K1H 816
    Clinique médicale l'Actuel
    Montréal, Quebec, Canada, H2L4P9
    Clinique Médical du Quartier Latin
    Montréal, Quebec, Canada, H2L5B1
    Montreal Chest Institute, Immunodeficiency Dept.
    Montréal, Quebec, Canada, H2X 2P4

    Sponsors and Collaborators

    Argos Therapeutics

    Investigators

    Principal Investigator: Jeffery Jacobson, MD Drexel University
    More Information

    More Information

    Additional Information:

    Sponsor Website

    Responsible Party: Argos Therapeutics  
    ClinicalTrials.gov Identifier: NCT01069809   History of Changes  
    Other Study ID Numbers: AGS-004-003  
      HHSN266200600019C  
      ES-11702  
    Study First Received: February 16, 2010  
    Last Updated: January 23, 2017  
    Individual Participant Data    
    Plan to Share IPD: No  

    Additional relevant MeSH terms:
    HIV Infections

    ClinicalTrials.gov processed this data on October 19, 2017
    This information is provided by ClinicalTrials.gov.