Safety and Efficacy Study of AGS-004 During Analytical Treatment Interruption
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01069809|
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : January 24, 2017
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Biological: AGS-004 Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Study Start Date :||July 2010|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||September 2015|
HIV-1 Immune Therapy
HIV-1 Immune Therapy
Placebo Comparator: Inactive Injection
Inactive Placebo Injection
Inactive Placebo Injection
- 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 ]
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069809
|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|
|Principal Investigator:||Jeffery Jacobson, MD||Drexel University|
|Responsible Party:||Argos Therapeutics|
|Other Study ID Numbers:||
HHSN266200600019C ( Other Identifier: NIH Contract )
ES-11702 ( Other Identifier: DAIDS )
|First Posted:||February 17, 2010 Key Record Dates|
|Last Update Posted:||January 24, 2017|
|Last Verified:||January 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases