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HIV InfectionsPhase 2NCT00672191

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

A Phase 2 study testing AGS-004 in people with HIV Infections, run by Argos Therapeutics at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
HIV Infections
What is being tested?
AGS-004
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
12 sitesin 2 countries
Study dates
Feb 2008to Nov 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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
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  • 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
  • Type I diabetes mellitus (insulin therapy for Type II diabetes is permitted)
  • Participation in another clinical trial within 30 days of Screening or use of investigational agents (previous use of expanded access ARTs is permitted)
  • Body weight less than 30 kg.
  • Changes in ART regimen due to virologic failure (not including toxicities)
  • Presence of factors predicting insufficient adherence to the protocol.
  • Any condition that in the assessment of the investigator would indicate that it is not in the best interest of the subject or incompatible with the any aspect of the study design, treatment plan, and study objectives for a subject to participate.
  • History or other evidence of severe illness, malignancy, or any other condition that would make the subject, in the opinion of the investigator, unsuitable for the study.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Canada11 sites

  • Southern Alberta Clinic

    Calgary, Alberta, T2R0X7

  • Hamilton Health Sciences - McMaster University Medical Centre

    Hamilton, Ontario, L7R3X5

  • Clinique medicale l'Actuel

    Montreal, Quebec, H2L4P9

  • Clinique Medical du Quartier Latin

    Montreal, Quebec, H2L5B1

  • Montreal Chest Institute

    Montreal, Quebec, H2X 2P4

  • CHUM

    Montreal, Quebec

  • The Ottawa Hospital

    Ottawa, Ontario, K1H8L6

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N3M5

  • Maple Leaf Clinic

    Toronto, Ontario, M5B 1L6

  • UHN

    Toronto, Ontario, M5G2C4

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

    Vancouver, British Columbia, V6Z1Y6

Other trials in Canada

United States1 site

  • Practice Comprehensive Care Practice Div of Onfectious Disease & HIV Med

    Philadelphia, Pennsylvania, 19102

Other trials in United States

About this study

Official title: A Phase II Study Testing the Activity and Safety of AGS-004 as an Immunotherapeutic in Successfully ART-Treated Subjects Infected With HIV-1 in Combination With ART Followed by ART Interruption

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.

Read the detailed description

Although chronic ART raises cluster of differentiation CD 4+ T cell counts and improves immune function, the immune systems' ability to control HIV-1 replication is not improved. AGS-004 is an immunotherapeutic agent made from autologous DCs co electroporated with amplified in vitro transcribed (IVT) ribonucleic acid (RNA) encoding CD40L and with IVT RNA encoding three or four autologous HIV-1 antigens. The HIV-1 RNA is derived from the plasma sample taken immediately prior to the initiation of ART.

Conditions
HIV Infections
Being tested
AGS-004
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
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGS-004Biological

    HIV-1 Immune Therapy

Study groups in NCT00672191
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Biological: AGS-004

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Study Week 26 through end of study

Secondary outcomes (3)

  1. Change in plasma HIV-1 RNA set point

    Measured: Study Week 26 through end of study

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

    Measured: Study Week 26 through end of study

  3. Safety and tolerability of AGS-004

    Measured: Study Week 26 through end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionAug 2010
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00672191
Sponsor's protocol ID
AGS-004-001
Status last verified
Jan 2013
First submitted
5 May 2008
Last updated
29 Jan 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AGS-004 in people with HIV Infections, run by Argos Therapeutics at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ability of AGS-004 therapy to improve immune control of HIV-1 replication (time frame: Study Week 26 through end of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00672191.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2013.

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