Phase II Study of AGS-004 as an Immunotherapeutic in Antiretroviral Therapy (ART)-Treated Subjects Infected With HIV

NCT00672191 | Completed Phase 2 DMC

• 1 other identifier: AGS-004-001
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 12

Brief Summary

The purpose of this study is to examine the ability of AGS-004 to control HIV-1 replication and to determine if HIV-1 immunotherapy made with dendritic cells is safe and well tolerated, to determine if immunotherapy increases the body's immune response to HIV-1; and, to determine if after stopping anti-HIV drugs, immunotherapy can control the HIV-1 virus.

Conditions

HIV Infections

Keywords

HIV; Human immunodeficiency virus; Immunodeficiency Virus, Human; HIV-1; ART; antiretroviral therapy; HAART; highly active retroviral therapy; cluster of differentiation CD 4+ T cell counts; HIV-1 Subjects successfully ART treated; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Ability of AGS-004 therapy to improve immune control of HIV-1 replication

  Study Week 26 through end of study

Secondary Outcomes (3)

• Change in plasma HIV-1 RNA set point

  Study Week 26 through end of study

• T cell responses to AGS-004 therapy and exploratory studies to investigate the mechanism of action of AGS-004.

  Study Week 26 through end of study

• Safety and tolerability of AGS-004

  Study Week 26 through end of study

Study Arms (1)

1

EXPERIMENTAL

Biological: AGS-004

Interventions

AGS-004 BIOLOGICAL

HIV-1 Immune Therapy

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 60 years of age
• HIV-1 infection
• Subjects must be on their first ART regimen for at least 3 months: 2 NRTIs together with an NNRTI and/or at least 1 PI (prior changes to ART regimen are allowed if due to tolerability, guideline change, or to simply dosing but not for viral control)
• Durable viral suppression (below limit of detection) for at least 3 months prior ot Screening
• CD4+ T cell count ≥ 450 cells/mm3 for at least 90 days immediately prior to Screening
• Availability of ≥ 1.2 mL of continually frozen plasma (may have been thawed and refrozen only once) drawn no more than 90 days before starting ART and preferably within 30 days.
• Pre-ART plasma HIV-1 RNA levels of ≥ 15,000 copies/mL at the time the plasma was archived before commencing ART
• Pre-ART nadir CD4+ T cell count ≥ 200 cells/mm3 (cell count of \< 200 cells/mm3 on one occasion is allowed if subsequent pre-ART CD4+ cell counts were \> 200 cells/mm3 on at least two time points.
• Laboratory values obtained at Screening and confirmed just prior to Baseline Day 1:
• Creatinine ≤ 1.5 x upper limit of normal (ULN);
• AST (SGOT), ALT (SG'PT), and alkaline phosphatase ≤ 3 x ULN;
• ANC ≥ 750 cells/mm3;
• Hemoglobin ≥ 10 g/dL; and,
• Platelet count ≥ 75,000/mm3
• Female subjects of reproductive potential must have a negative serum or urine pregnancy test with a sensitivity of at most 50 mIU/mL performed within 30 days prior to Screening.

You may not qualify if:

• HIV-2 antibody positive.
• Positive test for other infectious diseases including:
• clinically active, untreated syphilis (positive rapid plasma regain test (RPR)
• clinically active hepatitis B infection (positive Hep B surface antigen HBsAg)
• active hepatitis C infection or any history of hepatitis C infection
• positive test for HTLV Type I or Type II antibody
• Any acute infection or serious medical illness within 14 days prior to study entry
• History of lymph node irradiation or dissection
• Pregnancy or breast-feeding
• Previous use of any HIV-1 immunotherapy, including IL-2
• Use of hydroxyurea within 30 days prior to Screening
• Immunodeficiency other than HIV-1 or requirements to take immuno-modulating concomitant medications
• Known allergy or sensitivity to the investigational immunotherapy or its formulation
• Use of systemic corticosteroids and use of topical steroids over a total area exceeding 15 cm2 within 4 weeks of Screening or anticipated need for periodic use of corticosteroids during the study
• Receipt of any immune modulators or suppressors within 30 days of Screening

Sponsors & Collaborators

• Argos Therapeutics: lead

Study Sites (12)

Practice Comprehensive Care Practice Div of Onfectious Disease & HIV Med

Philadelphia, Pennsylvania, 19102, United States

Location

Southern Alberta Clinic

Calgary, Alberta, T2R0X7, Canada

Location

Providence Health Care Society / The University of British Columbia / BC Centre for Excellence in HIV/AIDS

Vancouver, British Columbia, V6Z1Y6, Canada

Location

Hamilton Health Sciences - McMaster University Medical Centre

Hamilton, Ontario, L7R3X5, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N3M5, Canada

Location

Maple Leaf Clinic

Toronto, Ontario, M5B 1L6, Canada

Location

UHN

Toronto, Ontario, M5G2C4, Canada

Location

Clinique medicale l'Actuel

Montreal, Quebec, H2L4P9, Canada

Location

Clinique Medical du Quartier Latin

Montreal, Quebec, H2L5B1, Canada

Location

Montreal Chest Institute

Montreal, Quebec, H2X 2P4, Canada

Location

CHUM

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Jean-Pierre Routy, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Mona Loutfy, MD

  Maple Leaf Clinic

  PRINCIPAL INVESTIGATOR

• Cecile Tremblay, MD

  CHUM- Hotel Dieu de Montreal

  PRINCIPAL INVESTIGATOR

• John Gill, MD

  Southern Alberta Clinic

  PRINCIPAL INVESTIGATOR

• Jean-Guy Baril, MD

  Clinque Medical du Quartier Latin

  PRINCIPAL INVESTIGATOR

• Sylvie Vezina, MD

  Clinque medicale l'Actuel

  PRINCIPAL INVESTIGATOR

• Jonathan B Angel, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

• Sharon Walmsley, MD

  UHN

  PRINCIPAL INVESTIGATOR

• Fiona Smaill, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

• Anita Rachlis, MD

  Sunnybrook Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Julio Montaner, MD

  Providence Health Care Society

  PRINCIPAL INVESTIGATOR

• Jeffrey Jacobson, MD

  Partnership Comprehensive Care Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 6, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: November 1, 2011
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

CA (11); US (1)