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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00672191

Run by

Argos Therapeutics

People needed

59

Starts

2008-02-01

Expected to finish

2011-11-01

Last updated by the study team

2013-01-29

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 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.
• All subjects must agree not to participate in a conception process and use contraception.
• Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
• Voluntary informed consent given to participate in the study.
• Successful RNA amplification of at least 3 antigens (must include Gag).

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
• Active autoimmune disease such as:
• Rheumatoid arthritis
• Inflammatory bowel disease
• Systemic lupus erythematosis
• Ankylosing spondylitis
• Hashimoto's disease
• Scleroderma
• Multiple sclerosis
• Autoimmune hemolytic anemia
• Immune thrombocytopenic purpura

Where it is running

• Practice Comprehensive Care Practice Div of Onfectious Disease & HIV Med — Philadelphia, Pennsylvania, United States
• Southern Alberta Clinic — Calgary, Alberta, Canada
• Providence Health Care Society / The University of British Columbia / BC Centre for Excellence in HIV/AIDS — Vancouver, British Columbia, Canada
• Hamilton Health Sciences - McMaster University Medical Centre — Hamilton, Ontario, Canada
• The Ottawa Hospital — Ottawa, Ontario, Canada
• Sunnybrook Health Sciences Center — Toronto, Ontario, Canada
• Maple Leaf Clinic — Toronto, Ontario, Canada
• UHN — Toronto, Ontario, Canada
• Clinique medicale l'Actuel — Montreal, Quebec, Canada
• Clinique Medical du Quartier Latin — Montreal, Quebec, Canada
• Montreal Chest Institute — Montreal, Quebec, Canada
• CHUM — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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