HIV SeropositivityPhase 1/2NCT00381212
A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent.
A Phase 1/2 study testing AGS-004 in people with HIV Seropositivity and Acquired Immunodeficiency Syndrome, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
To Investigate the safety and immunologic activity of AGS-004, an autologous HIV Immunotherapeutic, in HIV-infected adults currently on stable antiretroviral therapy (ART) with durable viral suppression. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Seropositivity, Acquired Immunodeficiency Syndrome
- What is being tested?
- AGS-004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Nov 2008
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women age 18 years and over,
- Documented HIV-1 infection,
- Durable viral suppression (≤ 200 copies HIV-1 RNA / mL) on first ART regimen for at least 12 weeks prior to entry,
- Availability of ≥ 2.5mL of continually-frozen plasma before starting ART (≥30,000 copies/mL),
- CD4+ T cell count ≥200 cells/mm3 at time of pre-ART sample,
- CD4+ T cell count of ≥350 cells/mm3 obtained within 4 weeks of study entry,
Who cannot join
- No co-infection with HBV or HCV,
- No history of lymph node irradiation or dissection,
- No prior use of any HIV vaccine,
- No use of hydroxyurea,
- No use of systemic corticosteroids or other non-permitted medications,
Trial locations and contacts
1 site in 1 country.
Canada1 site
Immunodeficiency Service/Montreal Chest Institute
Montreal, Quebec, H2X 2P4
About this study
Official title: A Pilot Study (Phase I/II) Testing the Immunologic Activity and Safety of AGS-004, an Autologous HIV Immunotherapeutic, in HIV-Infected Adults on HAART
To Investigate the safety and immunologic activity of AGS-004, an autologous HIV Immunotherapeutic, in HIV-infected adults currently on stable antiretroviral therapy (ART) with durable viral suppression.
Read the detailed description
Although an HIV infection can induce weak immune responses, current HIV immunotherapy using consensus antigens has not shown consistent clinical activity. The absence of clinical activity is associated with an inability to raise cytotoxic T lymphocytes (CTL) against HIV antigens and a failure to induce T cell memory. While strong immune responses may be generated to a consensus antigen, those responses do not offer antiviral protection against a patient's individual viral burden. The infecting virus' antigen variability likely prevents the establishment of effective CD4+ T cell memory and a strong CD8+ T cell effector arm.
We are investigating the induction of CTL responses in HIV-infected subjects by a novel HIV immunotherapeutic agent (AGS-004) in an effort to overcome the lack of polyvalent specificity of the immune response for autologous HIV antigens which has been one of the primary reasons for the failure of HIV immunotherapy to date.
This pilot study will investigate the safety and immunologic activity of AGS-004 an autologous HIV immunotherapeutic agent.
- Being tested
- AGS-004
- Keywords
- Immunotherapeutic injection
- Medical subject headings
- HIV Seropositivity, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGS-004Biological
Also called AGS-004 immunotherapeutic
Four intradermal injections of AGS-004-001 immunotherapeutic, 4 weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AGS-004 immunotherapeutic injections. Receives: Biological: AGS-004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunologic activity of AGS-004 will be as measured by flow cytometry
Measured: 18 weeks
Secondary outcomes (1)
To determine the safety of AGS-004 in the entire study population by frequency and severity of treatment emergent adverse events
Measured: 66 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionFeb 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, Argos Therapeutics
- Investigators
- Jean-Pierre Routy, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381212
- Sponsor's protocol ID
- BMB#06-003
- Other IDs
- CAN-HIV-001, CTN229
- Status last verified
- Jan 2009
- First submitted
- 25 Sep 2006
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study (Phase I/II) Testing the Immunologic Activity and Safety of AGS-004, an Autologous HIV Immunotherapeutic, in HIV-Infected Adults on HAART
- ClinicalTrials.gov ID
- NCT00381212
- Acronym / sponsor ID
- BMB#06-003
- Keywords
- Immunotherapeutic injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Université de Montréal, Argos Therapeutics
- Study start
- Sep 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 27 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Investigate the safety and immunologic activity of AGS-004, an autologous HIV Immunotherapeutic, in HIV-infected adults currently on stable antiretroviral therapy (ART) with durable viral suppression.
Detailed description
Although an HIV infection can induce weak immune responses, current HIV immunotherapy using consensus antigens has not shown consistent clinical activity. The absence of clinical activity is associated with an inability to raise cytotoxic T lymphocytes (CTL) against HIV antigens and a failure to induce T cell memory. While strong immune responses may be generated to a consensus antigen, those responses do not offer antiviral protection against a patient's individual viral burden. The infecting virus' antigen variability likely prevents the establishment of effective CD4+ T cell memory and a strong CD8+ T cell effector arm.
We are investigating the induction of CTL responses in HIV-infected subjects by a novel HIV immunotherapeutic agent (AGS-004) in an effort to overcome the lack of polyvalent specificity of the immune response for autologous HIV antigens which has been one of the primary reasons for the failure of HIV immunotherapy to date.
This pilot study will investigate the safety and immunologic activity of AGS-004 an autologous HIV immunotherapeutic agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: AGS-004AGS-004 immunotherapeutic injections. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women age 18 years and over,
- Documented HIV-1 infection,
- Durable viral suppression (≤ 200 copies HIV-1 RNA / mL) on first ART regimen for at least 12 weeks prior to entry,
- Availability of ≥ 2.5mL of continually-frozen plasma before starting ART (≥30,000 copies/mL),
- CD4+ T cell count ≥200 cells/mm3 at time of pre-ART sample,
Key exclusion criteria (5 listed)
- No co-infection with HBV or HCV,
- No history of lymph node irradiation or dissection,
- No prior use of any HIV vaccine,
- No use of hydroxyurea,
- No use of systemic corticosteroids or other non-permitted medications,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGS-004Also: AGS-004 immunotherapeuticFour intradermal injections of AGS-004-001 immunotherapeutic, 4 weeks apart. | Biological | 1 |
Primary outcome
Immunologic activity of AGS-004 will be as measured by flow cytometry
Time frame: 18 weeks
1 secondary outcome
To determine the safety of AGS-004 in the entire study population by frequency and severity of treatment emergent adverse events
Time frame: 66 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pierre Routy, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AGS-004 in people with HIV Seropositivity and Acquired Immunodeficiency Syndrome, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 6 inclusion and 5 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 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Immunologic activity of AGS-004 will be as measured by flow cytometry (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2009.