Safety and Efficacy Study of AGS-004 During Analytical Treatment Interruption

A Phase 2 study testing AGS-004 in people with HIV Infection, run by Argos Therapeutics at 9 sites in 2 countries.

Completed

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

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: HIV Infection
What is being tested?: AGS-004
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 53 participants
Where: 9 sitesin 2 countries
Study dates: Jul 2010to Sep 2015
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

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.

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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.

Who cannot join

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.

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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;
Serum total bilirubin > 1.8 X ULN, unless history of Gilbert's disease or deemed related to treatment with atazanavir.
History or other clinical evidence of significant or unstable cardiac disease (e.g., angina, congestive heart failure, recent myocardial infarction, significant arrhythmia) or clinically significant electrocardiogram (ECG) abnormalities.
History of moderate or severe renal impairment (i.e., persistent history of creatinine clearance < 50 mL/min) or any other renal disorder deemed clinically significant by the investigator.
Prior history of an acquired immunodeficiency syndrome (AIDS) defining condition.
History or other evidence of severe illness, malignancy, immunodeficiency other than HIV, or any other condition that would make the subject unsuitable for the study in the opinion of the investigator.
Known allergy or sensitivity to the components of the investigational immunotherapy.
Active drug or alcohol use or dependence that would interfere with adherence to study requirements in the opinion of the investigator.
Use of systemic corticosteroids and use of topical steroids over a total area exceeding 15 cm² within 30 days prior to Screening.
Any investigational antiretroviral agents or use of a CCR5 inhibitor at Screening.
Active autoimmune disease or condition.
Participation in another investigational clinical study within the previous 30 days or use of investigational agents.
Body weight less than 30 kg.

Trial locations and contacts

9 sites in 2 countries.

Country

City, postcode or hospital

9 sites in 2 countries

United States5 sites

AIDS Clinical Trials Unit
Chapel Hill, North Carolina, 27514
Duke University Medical Center
Durham, North Carolina, 27710
Division of Infectious Disease and HIV Medicine Partnership Comprehensive Care Practice
Philadelphia, Pennsylvania, 191002
UCDavis Research Office at CARES
Sacramento, California, 95811
Jacobi & North Central Bronx Hospitals
The Bronx, New York, 10461

Other trials in United States

Canada4 sites

Clinique médicale l'Actuel
Montreal, Quebec, H2L4P9
Clinique Médical du Quartier Latin
Montreal, Quebec, H2L5B1
Montreal Chest Institute, Immunodeficiency Dept.
Montreal, Quebec, H2X 2P4
The Ottawa Hospital
Ottawa, Ontario, K1H 816

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Phase 2B Study Testing the Efficacy and Safety of AGS-004 on Host Control of HIV Replication During Analytical Treatment Interruption

Read the detailed description

Conditions: HIV Infection
Being tested: AGS-004, Placebo
Medical subject headings: HIV Infections

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
PlaceboBiological
Inactive Placebo Injection

Study groups in NCT01069809
Study group	Role	What they receive
AGS-004	Experimental	HIV-1 Immune Therapy Receives: Biological: AGS-004
Inactive Injection	Placebo comparator	Inactive Placebo Injection Receives: Biological: Placebo

What is being measured

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

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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 2 years
Evaluate AGS-004 versus Placebo for change in inflammatory markers over treatment period and ATI
Measured: 38 Weeks (62 weeks for subjects continuing ATI in Step 4)
Study immunogenicity and mechanism of action by evaluating AGS-004 versus Placebo for change from Baseline in T-cell response.
Measured: 2 years
Study immunogenicity and mechanism of action by evaluating AGS-004 versus Placebo for change from Baseline of the extent of viral evolution.
Measured: 2 years
Study immunogenicity and mechanism of action by evaluating AGS-004 versus Placebo for change from Baseline in the chromosomally integrated viral reservoir.
Measured: 2 years

Timeline

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

Jul 2010Sep 2015

First posted17 Feb 2010 (estimated)
Study startJul 2010
Primary completionAug 2014
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01069809
Sponsor's protocol ID: AGS-004-003
Other IDs: HHSN266200600019C, ES-11702
Status last verified: Jan 2017
First submitted: 16 Feb 2010
Last updated: 24 Jan 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Phase 2B Study Testing the Efficacy and Safety of AGS-004 on Host Control of HIV Replication During Analytical Treatment Interruption
ClinicalTrials.gov ID: NCT01069809
Acronym / sponsor ID: AGS-004-003
Conditions: HIV Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Argos TherapeuticsIndustry (pharma, biotech, devices)
Study start: Jul 2010 (actual)
Primary completion: Aug 2014 (actual)
Study completion: Sep 2015 (actual)
First posted: 17 Feb 2010 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
AGS-004	Experimental	Biological: AGS-004HIV-1 Immune Therapy
Inactive Injection	Placebo comparator	Biological: PlaceboInactive Placebo Injection

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (27 listed)

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.

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-004HIV-1 Immune Therapy	Biological	AGS-004
PlaceboInactive Placebo Injection	Biological	Inactive Injection

Primary outcome

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
Time frame: 38 weeks

8 secondary outcomes

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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 2 years
Evaluate AGS-004 versus Placebo for change in inflammatory markers over treatment period and ATI
Time frame: 38 Weeks (62 weeks for subjects continuing ATI in Step 4)
Study immunogenicity and mechanism of action by evaluating AGS-004 versus Placebo for change from Baseline in T-cell response.
Time frame: 2 years
Study immunogenicity and mechanism of action by evaluating AGS-004 versus Placebo for change from Baseline of the extent of viral evolution.
Time frame: 2 years
Study immunogenicity and mechanism of action by evaluating AGS-004 versus Placebo for change from Baseline in the chromosomally integrated viral reservoir.
Time frame: 2 years

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 24 Jan 2017.
Sponsor WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for HIV Infection

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
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Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
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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.

Jeffery Jacobson, MD principal investigator

Drexel University

9 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AGS-004 in people with HIV Infection, run by Argos Therapeutics at 9 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 11 inclusion and 27 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, 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. Some participants in this study may receive a placebo. 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?

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 (time frame: 38 weeks). 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 NCT01069809.

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 24 Jan 2017.