NCT01069809
Completed
Phase 2
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
Argos Therapeutics9 sites in 2 countries53 target enrollmentStarted: July 2010Last updated:
ConditionsHIV Infection
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Argos Therapeutics
- Enrollment
- 53
- Locations
- 9
- Primary Endpoint
- 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
Overview
Brief Summary
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.
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
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).
Outcomes
Primary Outcomes
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 Outcomes
- Study immunogenicity and mechanism of action by evaluating AGS-004 versus Placebo for change from Baseline in the chromosomally integrated viral reservoir.(2 years)
- 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)(38 weeks (62 weeks for subjects continuing ATI in Step 4))
- Evaluate AGS-004 versus Placebo for change in inflammatory markers over treatment period and ATI(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 of the extent of viral evolution.(2 years)
- 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)(38 weeks (62 weeks for subjects continuing ATI in Step 4))
- 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.(38 weeks)
- Evaluate AGS-004 versus Placebo for change from Baseline in TEAEs, clinical laboratory evaluations, and clinical assessments.(2 years)
- Study immunogenicity and mechanism of action by evaluating AGS-004 versus Placebo for change from Baseline in T-cell response.(2 years)
Investigators
Study Sites (9)
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