HIV InfectionPhase 2NCT00131560
Safety and Efficacy of T Cell Genetic Immunotherapy for HIV
A Phase 2 study testing VRX496-Modified Autologous T cells in people with HIV Infection, run by VIRxSYS Corporation at 5 sites in United States.
Trial summary
This study uses autologous (one's own) CD4 T cells modified with a viral vector expressing a genetic antisense targeting HIV, this vector is called VRX496. Study treatment is by intravenous infusion of vector modified cells and infusions will be provided every other week for a total of 4 or 8 doses. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- VRX496-Modified Autologous T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2005to 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sero-positive for infection with HIV and failed, or be intolerant to, at least one triple combination of antiretroviral agent
- If on antiretroviral therapy, subject must be willing to continue on current antiretroviral therapy; or if discontinues antiretroviral therapy must have a wash-out period of 6 weeks prior to screening; or if not on antiretroviral therapy must be willing to remain off antiretroviral therapy for the duration of the study (i.e. up to 1 year)
- Male or female, 18 years of age and older
- Karnofsky Performance score of 80 or higher
- Stable HIV viral load between 5,000 and 200,000 copies/mL at the time of screening. Stable will be defined as a variation of less than 0.5 log10 in the 3 months prior to screening while on a stable regimen or no therapy
- CD4 T cell count equal to or greater than 150 cells per μL at the time of screening
Show all 9Show fewer
- A body weight greater than 50 Kg
- Adequate venous access and no other contraindications for leukapheresis
- Subject must be willing to comply with study-mandated evaluations
Who cannot join
- A history of any type of cancer or malignancy, with the exception of (successfully) treated basal cell or squamous cell carcinoma of the skin
- A history or any features on physical examination indicative of cardiac disease or hemodynamic instability
- Any history or any features on physical examination indicative of a bleeding diathesis
- Previous treatment with any HIV experimental vaccine or any gene therapy products
- A positive signal for VSV-G antibodies and/or VSV-G DNA in the blood at screening
- Any of the following lab results:
Show all 20Show fewer
- Hemoglobin: <10 (males); <9.5 (females) g/dL
- Absolute neutrophil count: < 1000/μL
- Platelet count: <100,000/mm3
- Serum creatinine: > 1.5 mg/dL (133µ mol/L)
- AST or ALT: > 2.5 times the upper limit of normal
- Total serum bilirubin: > 1.5 times the upper limit of normal
- Proteinuria: 2+ on urine dipstick
- Subjects must not be breastfeeding, be pregnant, or unwilling to use acceptable methods of birth control
- Subjects must not be on chronic oral corticosteroids within 30 days of screening - (if subjects are prescribed a brief course of oral corticosteroids the use should be limited to less than 1 week), hydroxyurea, or immunomodulating agents (e.g., IL 2, interferon-gamma, granulocyte colony stimulating factors, etc.) within 30-days of screening or foreseeably need any of these within the study period
- Subjects must not be using aspirin, dipyridamole, warfarin or any other medication likely to affect platelet function or other aspects of blood coagulation during the period when leukapheresis is scheduled
- Subjects must not suffer from active drug or alcohol dependence or abuse, to an extent that, in the opinion of the investigator, would interfere with their ability to comply with study requirements
- Any serious illnesses or acute opportunistic infection
- Any other illness or condition which in the opinion of the investigator would exclude the subject from the study
- Subjects unable or unwilling to give written informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Kentucky
Lexington, Kentucky, 40536
Steinhart Medical Associates
Miami, Florida, 33133
CIRCLE Medical, LLC
Norwalk, Connecticut, 06851
Stanford AIDS Clinical Trials Unit
Palo Alto, California, 94304
Jacobi Medical Center
The Bronx, New York, 10461
About this study
Official title: A Phase II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Biological Activity of Single and Repeated Doses of Autologous T Cells Transduced With VRX496 in HIV-Positive Subjects
This study uses autologous (one's own) CD4 T cells modified with a viral vector expressing a genetic antisense targeting HIV, this vector is called VRX496. Study treatment is by intravenous infusion of vector modified cells and infusions will be provided every other week for a total of 4 or 8 doses. These modified cells, once infused, may provide immune support and are not destroyed by HIV, and thus may delay or reverse HIV disease progression. The study will enroll up to 40 male and female HIV-positive subjects in up to 8 centers. Subjects will be 18 years of age and over who have failed or are intolerant to at least one triple combination of antiretroviral drugs. Subjects must have a viral load between 5,000 and 200,000 copies/ml and a CD4+ count of ≥150, be in good health and have no evidence of active opportunistic infection, heart disease, or bleeding disorders. Subjects must not be on corticosteroids, immunomodulating agents or hydroxyurea. Subjects must not have received an AIDS vaccine or any investigational gene therapy product at any time. Females must not be pregnant or breastfeeding.
Read the detailed description
VIRxSYS has concluded a 6-month Phase 1/2 clinical study under an IND of the vector VRX496 in HIV-positive subjects who have failed at least two HAART regimens. HAART typically consists of a triple "cocktail" of drugs. Although these cocktails have been successful in reducing viral loads and restoring immune function, they do not represent a cure. There are also concerns about adverse effects associated with long-term usage of HAART. Specifically, a variety of metabolic disorders including HIV-associated lipodystrophy, central adiposity, dyslipidaemia, hyperlipidaemia, hyperglycemia, and insulin resistance have been reported as resulting from HAART. These reactions, combined with often complex and cumbersome dosing regimens, can have an adverse effect on patient-subject adherence to therapy. Furthermore, poor adherence has led to increased rates of HIV resistance, resulting in viral strains that have reduced sensitivity to the drugs. Importantly, in the Phase 1/2 clinical trial conducted by VIRxSYS, there were no reported toxicities associated with the product.
Gene therapy for HIV-1 infection has been proposed as an alternative to antiretroviral drug regimens. A number of different genetic vectors with antiviral payloads have been utilized to combat HIV-1, including antisense RNA, transdominant proteins, ribozymes, RNA decoys, single chain antibodies, and RNAi (RNA-interference. Antisense RNA targeted to wt-HIV RNA offers a significant advantage over several other genetic antiviral approaches because it is not a protein and thus not immunogenic and because the size of the payload prevents virus escape mutants, such as occurs with the use of RNAi.
In this Phase 2 protocol, 6 subjects will be staggered for infusion by at least 2 weeks. The first group of 3 subjects will receive 4 infusions (4-dose cohort). If no dose limiting toxicities (DLT) are observed, the second group of 3 subjects, (i.e. subjects 4, 5 and 6) will continue with 8 infusions (8-dose cohort). Safety visits are scheduled 1 week after infusion and monthly for the first 6 months and at 9 months following the last infusion.
After safety has been evaluated, and in order to explore biological activity, additional subjects (6-10 evaluable subjects) will be entered into each cohort. Follow-up visits are scheduled 1 week after infusion and monthly for the first 6 months and at 9 months following the last infusion.
The effect of a single bolus will also be examined in a third cohort. The single bolus infusion will consist of the following cell doses: approximately 10 billion, 20 billion, and 30 billion, respectively. Subjects will be allotted to the respective cell dose groups according to the order in which they are enrolled. Three to 5 subjects will be allotted to the lower cell dose group and followed for safety for 4 weeks. After safety is evaluated, the next group (3 to 5 subjects) will be allotted to the next higher cell dose group and followed for safety for 4 weeks. If the intermediate cell dose group is determined to be safe, an additional 3 to 5 subjects will be allotted to the highest cell dose group. All subjects will be followed for safety at biweekly intervals for the first 4 weeks and thereafter at monthly intervals up to 6 months and then at 9 months.
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 Infection
- Being tested
- VRX496-Modified Autologous T cells
- Keywords
- HIV, gene therapy, leukapheresis, autologous CD4 T cell, lentivector
- 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-Modified Autologous T cellsGenetic
Genetic: Anti-HIV antisense
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Not described Receives: Genetic: VRX496-Modified Autologous T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in viral load
Measured: 1 Year
Change in CD4 counts
Measured: 1 Year
Safety
Measured: 15 Years
Secondary outcomes (3)
Immune function
Measured: 1 Year
AIDS related illness
Measured: 1 Year
Persistence of vector modified cells
Measured: 15 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionNov 2008
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VIRxSYS Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tessio Rebello, PhD, Study director, VIRxSYS Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131560
- Sponsor's protocol ID
- VRX496-USA-05-002
- Status last verified
- Jun 2011
- First submitted
- 16 Aug 2005
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manilla P, Rebello T, Afable C, Lu X, Slepushkin V, Humeau LM, Schonely K, Ni Y, Binder GK, Levine BL, MacGregor RR, June CH, Dropulic B. Regulatory considerations for novel gene therapy products: a review of the process leading to the first clinical lentiviral vector. Hum Gene Ther. 2005 Jan;16(1):17-25. doi: 10.1089/hum.2005.16.17.
PubMed 15703485Ni Y, Sun S, Oparaocha I, Humeau L, Davis B, Cohen R, Binder G, Chang YN, Slepushkin V, Dropulic B. Generation of a packaging cell line for prolonged large-scale production of high-titer HIV-1-based lentiviral vector. J Gene Med. 2005 Jun;7(6):818-34. doi: 10.1002/jgm.726.
PubMed 15693055Lu X, Humeau L, Slepushkin V, Binder G, Yu Q, Slepushkina T, Chen Z, Merling R, Davis B, Chang YN, Dropulic B. Safe two-plasmid production for the first clinical lentivirus vector that achieves >99% transduction in primary cells using a one-step protocol. J Gene Med. 2004 Sep;6(9):963-73. doi: 10.1002/jgm.593.
PubMed 15352069Lu X, Yu Q, Binder GK, Chen Z, Slepushkina T, Rossi J, Dropulic B. Antisense-mediated inhibition of human immunodeficiency virus (HIV) replication by use of an HIV type 1-based vector results in severely attenuated mutants incapable of developing resistance. J Virol. 2004 Jul;78(13):7079-88. doi: 10.1128/JVI.78.13.7079-7088.2004.
PubMed 15194784Humeau LM, Binder GK, Lu X, Slepushkin V, Merling R, Echeagaray P, Pereira M, Slepushkina T, Barnett S, Dropulic LK, Carroll R, Levine BL, June CH, Dropulic B. Efficient lentiviral vector-mediated control of HIV-1 replication in CD4 lymphocytes from diverse HIV+ infected patients grouped according to CD4 count and viral load. Mol Ther. 2004 Jun;9(6):902-13. doi: 10.1016/j.ymthe.2004.03.005.
PubMed 15194057
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 Phase II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Biological Activity of Single and Repeated Doses of Autologous T Cells Transduced With VRX496 in HIV-Positive Subjects
- ClinicalTrials.gov ID
- NCT00131560
- Acronym / sponsor ID
- VRX496-USA-05-002
- Conditions
- HIV Infection
- Keywords
- HIV, gene therapy, leukapheresis, autologous CD4 T cell, lentivector
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VIRxSYS CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 18 Aug 2005 (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.
This study uses autologous (one's own) CD4 T cells modified with a viral vector expressing a genetic antisense targeting HIV, this vector is called VRX496. Study treatment is by intravenous infusion of vector modified cells and infusions will be provided every other week for a total of 4 or 8 doses. These modified cells, once infused, may provide immune support and are not destroyed by HIV, and thus may delay or reverse HIV disease progression. The study will enroll up to 40 male and female HIV-positive subjects in up to 8 centers. Subjects will be 18 years of age and over who have failed or are intolerant to at least one triple combination of antiretroviral drugs. Subjects must have a viral load between 5,000 and 200,000 copies/ml and a CD4+ count of ≥150, be in good health and have no evidence of active opportunistic infection, heart disease, or bleeding disorders. Subjects must not be on corticosteroids, immunomodulating agents or hydroxyurea. Subjects must not have received an AIDS vaccine or any investigational gene therapy product at any time. Females must not be pregnant or breastfeeding.
Detailed description
VIRxSYS has concluded a 6-month Phase 1/2 clinical study under an IND of the vector VRX496 in HIV-positive subjects who have failed at least two HAART regimens. HAART typically consists of a triple "cocktail" of drugs. Although these cocktails have been successful in reducing viral loads and restoring immune function, they do not represent a cure. There are also concerns about adverse effects associated with long-term usage of HAART. Specifically, a variety of metabolic disorders including HIV-associated lipodystrophy, central adiposity, dyslipidaemia, hyperlipidaemia, hyperglycemia, and insulin resistance have been reported as resulting from HAART. These reactions, combined with often complex and cumbersome dosing regimens, can have an adverse effect on patient-subject adherence to therapy. Furthermore, poor adherence has led to increased rates of HIV resistance, resulting in viral strains that have reduced sensitivity to the drugs. Importantly, in the Phase 1/2 clinical trial conducted by VIRxSYS, there were no reported toxicities associated with the product.
Gene therapy for HIV-1 infection has been proposed as an alternative to antiretroviral drug regimens. A number of different genetic vectors with antiviral payloads have been utilized to combat HIV-1, including antisense RNA, transdominant proteins, ribozymes, RNA decoys, single chain antibodies, and RNAi (RNA-interference. Antisense RNA targeted to wt-HIV RNA offers a significant advantage over several other genetic antiviral approaches because it is not a protein and thus not immunogenic and because the size of the payload prevents virus escape mutants, such as occurs with the use of RNAi.
In this Phase 2 protocol, 6 subjects will be staggered for infusion by at least 2 weeks. The first group of 3 subjects will receive 4 infusions (4-dose cohort). If no dose limiting toxicities (DLT) are observed, the second group of 3 subjects, (i.e. subjects 4, 5 and 6) will continue with 8 infusions (8-dose cohort). Safety visits are scheduled 1 week after infusion and monthly for the first 6 months and at 9 months following the last infusion.
After safety has been evaluated, and in order to explore biological activity, additional subjects (6-10 evaluable subjects) will be entered into each cohort. Follow-up visits are scheduled 1 week after infusion and monthly for the first 6 months and at 9 months following the last infusion.
The effect of a single bolus will also be examined in a third cohort. The single bolus infusion will consist of the following cell doses: approximately 10 billion, 20 billion, and 30 billion, respectively. Subjects will be allotted to the respective cell dose groups according to the order in which they are enrolled. Three to 5 subjects will be allotted to the lower cell dose group and followed for safety for 4 weeks. After safety is evaluated, the next group (3 to 5 subjects) will be allotted to the next higher cell dose group and followed for safety for 4 weeks. If the intermediate cell dose group is determined to be safe, an additional 3 to 5 subjects will be allotted to the highest cell dose group. All subjects will be followed for safety at biweekly intervals for the first 4 weeks and thereafter at monthly intervals up to 6 months and then at 9 months.
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)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Genetic: VRX496-Modified Autologous T cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sero-positive for infection with HIV and failed, or be intolerant to, at least one triple combination of antiretroviral agent
- If on antiretroviral therapy, subject must be willing to continue on current antiretroviral therapy; or if discontinues antiretroviral therapy must have a wash-out period of 6 weeks prior to screening; or if not on antiretroviral therapy must be willing to remain off antiretroviral therapy for the duration of the study (i.e. up to 1 year)
- Male or female, 18 years of age and older
- Karnofsky Performance score of 80 or higher
- Stable HIV viral load between 5,000 and 200,000 copies/mL at the time of screening. Stable will be defined as a variation of less than 0.5 log10 in the 3 months prior to screening while on a stable regimen or no therapy
Key exclusion criteria (20 listed)
- A history of any type of cancer or malignancy, with the exception of (successfully) treated basal cell or squamous cell carcinoma of the skin
- A history or any features on physical examination indicative of cardiac disease or hemodynamic instability
- Any history or any features on physical examination indicative of a bleeding diathesis
- Previous treatment with any HIV experimental vaccine or any gene therapy products
- A positive signal for VSV-G antibodies and/or VSV-G DNA in the blood at screening
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-Modified Autologous T cellsGenetic: Anti-HIV antisense | Genetic | A |
Primary outcome
Change in viral load
Time frame: 1 Year
Change in CD4 counts
Time frame: 1 Year
Safety
Time frame: 15 Years
3 secondary outcomes
Immune function
Time frame: 1 Year
AIDS related illness
Time frame: 1 Year
Persistence of vector modified cells
Time frame: 15 Years
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.
- Background: PubMed 15703485Manilla P, Rebello T, Afable C, Lu X, Slepushkin V, Humeau LM, Schonely K, Ni Y, Binder GK, Levine BL, MacGregor RR, June CH, Dropulic B. Regulatory considerations for novel gene therapy products: a review of the process leading to the first clinical lentiviral vector. Hum Gene Ther. 2005 Jan;16(1):17-25. doi: 10.1089/hum.2005.16.17.
- Background: PubMed 15693055Ni Y, Sun S, Oparaocha I, Humeau L, Davis B, Cohen R, Binder G, Chang YN, Slepushkin V, Dropulic B. Generation of a packaging cell line for prolonged large-scale production of high-titer HIV-1-based lentiviral vector. J Gene Med. 2005 Jun;7(6):818-34. doi: 10.1002/jgm.726.
- Background: PubMed 15352069Lu X, Humeau L, Slepushkin V, Binder G, Yu Q, Slepushkina T, Chen Z, Merling R, Davis B, Chang YN, Dropulic B. Safe two-plasmid production for the first clinical lentivirus vector that achieves >99% transduction in primary cells using a one-step protocol. J Gene Med. 2004 Sep;6(9):963-73. doi: 10.1002/jgm.593.
- Background: PubMed 15194784Lu X, Yu Q, Binder GK, Chen Z, Slepushkina T, Rossi J, Dropulic B. Antisense-mediated inhibition of human immunodeficiency virus (HIV) replication by use of an HIV type 1-based vector results in severely attenuated mutants incapable of developing resistance. J Virol. 2004 Jul;78(13):7079-88. doi: 10.1128/JVI.78.13.7079-7088.2004.
- Background: PubMed 15194057Humeau LM, Binder GK, Lu X, Slepushkin V, Merling R, Echeagaray P, Pereira M, Slepushkina T, Barnett S, Dropulic LK, Carroll R, Levine BL, June CH, Dropulic B. Efficient lentiviral vector-mediated control of HIV-1 replication in CD4 lymphocytes from diverse HIV+ infected patients grouped according to CD4 count and viral load. Mol Ther. 2004 Jun;9(6):902-13. doi: 10.1016/j.ymthe.2004.03.005.
- VIRxSYS Corporation websiteLink provided by the sponsor.
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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 Rebello, PhD study director
VIRxSYS Corporation
5 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-Modified Autologous T cells in people with HIV Infection, run by VIRxSYS Corporation at 5 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 9 inclusion and 20 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 5 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?
Change in viral load (time frame: 1 Year). 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?
On the ClinicalTrials.gov record for NCT00131560, which also lists 5 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 8 Jun 2011.