HIV InfectionsPhase 2RolloverNCT00622232
A Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 Trial
A Phase 2 study testing VRX496-transduced autologous CD4 T cells in people with HIV Infections, run by VIRxSYS Corporation at 2 sites in United States.
Trial summary
The objective of this study is to determine the long term safety and tolerability of an additional infusion of 10 billion VRX496 gene-modified CD4 T cells with a focus on evaluating additional therapeutic benefits with respect to viral load and CD4 counts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- VRX496-transduced autologous CD4 T cells
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Jun 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements.
- Subjects who have successfully completed participation in the VRX496-USA-05-002 trial.
- Subjects who initiated or changed to a new ARV regimen more than 3 months prior to Entry Assessment are eligible.
- Subjects that who (1) if on ARVs and are willing to continue on the current therapy unchanged, or (2) if not on ARV willing to remain off ARVs for the duration of the trial i.e. 9 months. However, if there is clinical need to start or change ARV therapy, then it is permitted to do so.
Who cannot join
- CD4 counts decreased by ≥25% from baseline in main study.
- Viral load increased by ≥ 1.0 log from baseline in main study or ≥ 200,000.
- Female subjects who are of reproductive potential who have a positive serum B HCG at the Entry Assessment visit or are not willing to use a reliable method of barrier contraception.
- Are breast-feeding.
- Subjects who are actively using injection drugs or other substance abuse (such as extensive alcohol or narcotic use).
- Any medical condition(s) which, in the opinion of the investigator, would interfere with the subject's ability to participate in or adhere to the requirements of this protocol
- Active HIV-related or non HIV-related illness
- Subjects who do not have additional cell product available
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jacobi Medical Center
New York, New York, 10461
CIRCLE Medical, LLC
Norwalk, Connecticut, 06851
About this study
Official title: A Rollover Study to Evaluate Safety and Therapeutic Effect of Re-infusing Subjects Who Completed Participation in the VRX496-USA-05-002 Trial With Autologous T Cells Transduced With VRX496
The objective of this study is to determine the long term safety and tolerability of an additional infusion of 10 billion VRX496 gene-modified CD4 T cells with a focus on evaluating additional therapeutic benefits with respect to viral load and CD4 counts.
Read the detailed description
The study has concluded it's 9-month active phase. Subjects are currently in a 15-year Long Term Follow-up Phase of the study.
In keeping with the recently released Guidance on Monitoring For Delayed Adverse Events, that states that for the first 5 years all subjects should undergo monitoring of vector sequences every 6 months, subjects will visit the clinic at a maximum of 6 months intervals for a blood test evaluating persistence of vector sequences.
Therefore for the first 5 years, subjects will have 6 months visits for safety assessment. For years 6 to 15, subjects will be contacted by phone or mail. At these contacts, subjects will be asked about their health status.
- Conditions
- HIV Infections
- Being tested
- VRX496-transduced autologous CD4 T cells
- Keywords
- HIV-1, treatment experienced, complementary therapies
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRX496-transduced autologous CD4 T cellsGenetic
The cell dose will consist of approximately 10 billion VRX496-transduced autologous CD4 T cells provided as a single bolus infusion.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of an additional infusion of VRX496 CD4+ T cells in subjects who previously received VRX496 CD4 T cells under protocol VRX496-USA-05-002.
Measured: 9 months
To evaluate the change in log10 HIV-1 RNA level
Measured: 9 months
To evaluate the change between main study baseline CD4 counts and Month 9 post reinfusion
Measured: 9 months
Secondary outcomes (1)
Changes in immune function as determined by ICS and TCR vβ Repertoire profile.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionJan 2009
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VIRxSYS Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tessio E Rebello, PhD, Study director, VIRxSYS CorporationDavid Stein, M.D., Principal investigator, Jacobi Medical CenterGary Blick, M.D., Principal investigator, CIRCLE Medical, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622232
- Sponsor's protocol ID
- VRX496-USA-05-002-Rollover
- Acronym
- Rollover
- Status last verified
- Jun 2011
- First submitted
- 11 Feb 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rollover Study to Evaluate Safety and Therapeutic Effect of Re-infusing Subjects Who Completed Participation in the VRX496-USA-05-002 Trial With Autologous T Cells Transduced With VRX496
- ClinicalTrials.gov ID
- NCT00622232
- Acronym / sponsor ID
- Rollover / VRX496-USA-05-002-Rollover
- Conditions
- HIV Infections
- Keywords
- HIV-1, treatment experienced, complementary therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- VIRxSYS CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 22 Feb 2008 (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.
The objective of this study is to determine the long term safety and tolerability of an additional infusion of 10 billion VRX496 gene-modified CD4 T cells with a focus on evaluating additional therapeutic benefits with respect to viral load and CD4 counts.
Detailed description
The study has concluded it's 9-month active phase. Subjects are currently in a 15-year Long Term Follow-up Phase of the study.
In keeping with the recently released Guidance on Monitoring For Delayed Adverse Events, that states that for the first 5 years all subjects should undergo monitoring of vector sequences every 6 months, subjects will visit the clinic at a maximum of 6 months intervals for a blood test evaluating persistence of vector sequences.
Therefore for the first 5 years, subjects will have 6 months visits for safety assessment. For years 6 to 15, subjects will be contacted by phone or mail. At these contacts, subjects will be asked about their health status.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements.
- Subjects who have successfully completed participation in the VRX496-USA-05-002 trial.
- Subjects who initiated or changed to a new ARV regimen more than 3 months prior to Entry Assessment are eligible.
- Subjects that who (1) if on ARVs and are willing to continue on the current therapy unchanged, or (2) if not on ARV willing to remain off ARVs for the duration of the trial i.e. 9 months. However, if there is clinical need to start or change ARV therapy, then it is permitted to do so.
Key exclusion criteria (8 listed)
- CD4 counts decreased by ≥25% from baseline in main study.
- Viral load increased by ≥ 1.0 log from baseline in main study or ≥ 200,000.
- Female subjects who are of reproductive potential who have a positive serum B HCG at the Entry Assessment visit or are not willing to use a reliable method of barrier contraception.
- Are breast-feeding.
- Subjects who are actively using injection drugs or other substance abuse (such as extensive alcohol or narcotic use).
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 |
|---|---|---|
| VRX496-transduced autologous CD4 T cellsThe cell dose will consist of approximately 10 billion VRX496-transduced autologous CD4 T cells provided as a single bolus infusion. | Genetic | – |
Primary outcome
To evaluate the safety and tolerability of an additional infusion of VRX496 CD4+ T cells in subjects who previously received VRX496 CD4 T cells under protocol VRX496-USA-05-002.
Time frame: 9 months
To evaluate the change in log10 HIV-1 RNA level
Time frame: 9 months
To evaluate the change between main study baseline CD4 counts and Month 9 post reinfusion
Time frame: 9 months
1 secondary outcome
Changes in immune function as determined by ICS and TCR vβ Repertoire profile.
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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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.
Tessio E Rebello, PhD study director
VIRxSYS Corporation
David Stein, M.D. principal investigator
Jacobi Medical Center
Gary Blick, M.D. principal investigator
CIRCLE Medical, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VRX496-transduced autologous CD4 T cells in people with HIV Infections, run by VIRxSYS Corporation at 2 sites in United States.
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 8 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: status not confirmed, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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?
Results are not available in the source record.
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?
To evaluate the safety and tolerability of an additional infusion of VRX496 CD4+ T cells in subjects who previously received VRX496 CD4 T cells under protocol VRX496-USA-05-002. (time frame: 9 months). The study lists 3 primary outcomes in all. 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 8 Jun 2011.