HIV InfectionPhase 1/2NCT02766049

Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus

A Phase 1/2 study testing DC, DC10e6+HIV-AT2 and DC10e7+HIV-AT2 in people with HIV Infection, run by University of Sao Paulo General Hospital.

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 aim of this study was to assess tolerability and safety of three different formulations of an anti-HIV immunotherapy based on autologous dendritic cells (DCs) pulsed with HIV chemically inactivated with Aldrithiol™-2 (AT-2). Patients were chronically infected with HIV, naïve for antiretroviral drugs. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infection
What is being tested?: DC, DC10e6+HIV-AT2 and DC10e7+HIV-AT2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: No sites listed yet
Study dates: Feb 2010to May 2014
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

patients with HIV infection;
absence of antiretroviral therapy, antineoplastic therapy or the use of corticosteroids for at least six months prior to study entry;
plasma viral load ≥ 1,000 copies / mL, stable (ie no variation > 0.5 log) in the six months before the start of the study;
blood CD4+ T cells ≥ 350 /mL, stable (ie no variation > 25%) in the six months before the start of the study.

Who cannot join

individuals without proper venous access for blood and apheresis collection procedure.
use of drugs, alcohol, psychiatric disorder or any condition that interferes with the ability of patients to follow the requirements of the study;
history of diagnosis of HIV infection <01 years;
pregnancy or breast-feeding;
use of antiviral therapy, in anticancer therapies or corticosteroids six months prior to study start;
presence of chronic diseases, such as infection with hepatitis B (HBV) and C (HCV), human T-lymphotropic virus (HTLV) I / II or any condition that promotes immune system dysfunction, with the exception of HIV infection.

About this study

Official title: Phase I/II Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus

Conditions: HIV Infection
Being tested: DC, DC10e6+HIV-AT2, DC10e7+HIV-AT2
Keywords: HIV, immunotherapy, clinical trial, dendritic cell
Medical subject headings: HIV Infections

What participants receive

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

DCBiological
Autologous dendritic cells (3x10e7)
DC10e6+HIV-AT2Biological
Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV
DC10e7+HIV-AT2Biological
Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV

Study groups in NCT02766049
Study group	Role	What they receive
(a) DC	Active comparator	Autologous dendritic cells (3x10e7) Receives: Biological: DC
(b) DC 10e6+HIV-AT2	Active comparator	Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV Receives: Biological: DC10e6+HIV-AT2
(c) DC 10e7+HIV-AT2	Active comparator	Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV Receives: Biological: DC10e7+HIV-AT2

What is being measured

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

Number of participants with ≥ grade 3 adverse events related to product
AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004
Measured: 51 weeks

Secondary outcomes (2)

Number of participants with change in plasma viral load from baseline, over the observation period
Log10 change in HIV RNA
Measured: Baseline to 51 weeks
Number of participants with change in CD4+T cells from baseline, over the observation period
Absolute number change of CD4+T cells
Measured: Baseline to 51 weeks

Timeline

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

Feb 2010May 2014

First posted9 May 2016 (estimated)
Study startFeb 2010
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies of the same condition, open and under way.
More trials run by University of Sao Paulo General HospitalThe 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: Parallel groups
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02766049
Sponsor's protocol ID: CAPPesq-0239/09
Status last verified: May 2016
First submitted: 1 Apr 2016
Last updated: 20 Jul 2016
Results posted: No
Individual data sharing: No

Publications

Lu W, Arraes LC, Ferreira WT, Andrieu JM. Therapeutic dendritic-cell vaccine for chronic HIV-1 infection. Nat Med. 2004 Dec;10(12):1359-65. doi: 10.1038/nm1147. Epub 2004 Nov 28.
PubMed 15568033
Oshiro TM, de Almeida A, da Silva Duarte AJ. Dendritic cell immunotherapy for HIV infection: from theory to reality. Immunotherapy. 2009 Nov;1(6):1039-51. doi: 10.2217/imt.09.68.
PubMed 20635918

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?

Official record

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus
ClinicalTrials.gov ID: NCT02766049
Acronym / sponsor ID: CAPPesq-0239/09
Conditions: HIV Infection
Keywords: HIV, immunotherapy, clinical trial, dendritic cell
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: University of Sao Paulo General HospitalUniversity, hospital or other
Study start: Feb 2010
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 9 May 2016 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
(a) DC	Active comparator	Biological: DCAutologous dendritic cells (3x10e7)
(b) DC 10e6+HIV-AT2	Active comparator	Biological: DC10e6+HIV-AT2Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV
(c) DC 10e7+HIV-AT2	Active comparator	Biological: DC10e7+HIV-AT2Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

patients with HIV infection;
absence of antiretroviral therapy, antineoplastic therapy or the use of corticosteroids for at least six months prior to study entry;
plasma viral load ≥ 1,000 copies / mL, stable (ie no variation > 0.5 log) in the six months before the start of the study;
blood CD4+ T cells ≥ 350 /mL, stable (ie no variation > 25%) in the six months before the start of the study.

Key exclusion criteria (6 listed)

individuals without proper venous access for blood and apheresis collection procedure.
use of drugs, alcohol, psychiatric disorder or any condition that interferes with the ability of patients to follow the requirements of the study;
history of diagnosis of HIV infection <01 years;
pregnancy or breast-feeding;
use of antiviral therapy, in anticancer therapies or corticosteroids six months prior to study start;

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
DCAutologous dendritic cells (3x10e7)	Biological	(a) DC
DC10e6+HIV-AT2Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV	Biological	(b) DC 10e6+HIV-AT2
DC10e7+HIV-AT2Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV	Biological	(c) DC 10e7+HIV-AT2

Primary outcome

Number of participants with ≥ grade 3 adverse events related to product
Time frame: 51 weeks
AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004

2 secondary outcomes

Number of participants with change in plasma viral load from baseline, over the observation period
Time frame: Baseline to 51 weeks
Number of participants with change in CD4+T cells from baseline, over the observation period
Time frame: Baseline to 51 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 20 Jul 2016.
Background: PubMed 15568033Lu W, Arraes LC, Ferreira WT, Andrieu JM. Therapeutic dendritic-cell vaccine for chronic HIV-1 infection. Nat Med. 2004 Dec;10(12):1359-65. doi: 10.1038/nm1147. Epub 2004 Nov 28.
Background: PubMed 20635918Oshiro TM, de Almeida A, da Silva Duarte AJ. Dendritic cell immunotherapy for HIV infection: from theory to reality. Immunotherapy. 2009 Nov;1(6):1039-51. doi: 10.2217/imt.09.68.
Individual participant dataSharing planned: No

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Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
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Recruiting
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Recruiting
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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.

Alberto JS Duarte, Professor principal investigator

University of Sao Paulo

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DC, DC10e6+HIV-AT2 and DC10e7+HIV-AT2 in people with HIV Infection, run by University of Sao Paulo General Hospital.

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 4 inclusion and 6 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 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Number of participants with ≥ grade 3 adverse events related to product (time frame: 51 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 NCT02766049, which also lists 2 linked publications.

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 20 Jul 2016.