NCT01069809

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_2

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

4.1 years

First QC Date

February 16, 2010

Last Update Submit

January 23, 2017

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (1)

  • 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

    38 weeks

Secondary Outcomes (8)

  • 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 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 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 from Baseline in TEAEs, clinical laboratory evaluations, and clinical assessments.

    2 years

  • 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)

  • +3 more secondary outcomes

Study Arms (2)

AGS-004

EXPERIMENTAL

HIV-1 Immune Therapy

Biological: AGS-004

Inactive Injection

PLACEBO COMPARATOR

Inactive Placebo Injection

Biological: Placebo

Interventions

AGS-004BIOLOGICAL

HIV-1 Immune Therapy

AGS-004
PlaceboBIOLOGICAL

Inactive Placebo Injection

Inactive Injection

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UCDavis Research Office at CARES

Sacramento, California, 95811, United States

Location

Jacobi & North Central Bronx Hospitals

The Bronx, New York, 10461, United States

Location

AIDS Clinical Trials Unit

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Division of Infectious Disease and HIV Medicine Partnership Comprehensive Care Practice

Philadelphia, Pennsylvania, 191002, United States

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 816, Canada

Location

Clinique médicale l'Actuel

Montreal, Quebec, H2L4P9, Canada

Location

Clinique Médical du Quartier Latin

Montreal, Quebec, H2L5B1, Canada

Location

Montreal Chest Institute, Immunodeficiency Dept.

Montreal, Quebec, H2X 2P4, Canada

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jeffery Jacobson, MD

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 17, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2014

Study Completion

September 1, 2015

Last Updated

January 24, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(5)CA(4)