Safety and Efficacy Study of AGS-004 During Analytical Treatment Interruption
Information provided by (Responsible Party)
First received: February 16, 2010
Last updated: January 23, 2017
Last Verified: January 2017
History of Changes
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.
Biological : AGS-004
Biological : Placebo
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 ]
- 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 ]
|Study Start Date:||July 2010|
|Study Completion Date:||September 2015|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
HIV-1 Immune Therapy
HIV-1 Immune Therapy
Inactive Placebo Injection
Inactive Placebo Injection
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 medicationEligibility
|Ages Eligible for Study:||18 Years to 60 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Males and females ≥ 18 to 60 years of age.
- HIV infection.
- Stable ART regimen for ≥ 3 months prior to Screening.
- HIV VL level ≤ 400 copies/mL for ≥ 2 months prior to Screening.
- HIV VL level ≤ 50 copies/mL at Screening.
- CD4+ T cell count ≥ 450 cells/mm3 at Screening.
- Pre-ART nadir CD4+ T cell counts ≥ 200 cells/mm³.
- Availability of an adequate sample of frozen plasma most recently collected (no more than 90 days and preferably within 30 days) before starting ART.
- Laboratory values within pre-defined limits at Screening and Eligibility.
- 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.
- Able and willing to give adequate written informed consent, to communicate effectively with study personnel, and willing to be compliant with protocol requirements.
- 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.
Contacts and LocationsChoosing 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 Show More
|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|
|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 CollaboratorsArgos Therapeutics
|Principal Investigator:||Jeffery Jacobson, MD||Drexel University|
Additional Information:Sponsor Website
|Responsible Party:||Argos Therapeutics|
|ClinicalTrials.gov Identifier:||NCT01069809 History of Changes|
|Other Study ID Numbers:||AGS-004-003|
|Study First Received:||February 16, 2010|
|Last Updated:||January 23, 2017|
|Individual Participant Data|
|Plan to Share IPD:||No|
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 11, 2017
This information is provided by ClinicalTrials.gov.