HIVPhase 1Zinc-FingerNCT00842634
Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 for HIV
A Phase 1 study testing ZFN modified T cells and Structured Treatment Interruption in people with HIV and HIV Infections, run by University of Pennsylvania at 2 sites in United States.
Trial summary
This research study is being carried out to study a new way to possibly treat HIV. This agent is called a "Zinc Finger Nuclease" or ZFN for short. ZFNs are proteins that can delete another protein named CCR5. This CCR5 protein is required for certain common types of HIV (CCR5 tropic) to enter into and infect T-cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- ZFN modified T cells and Structured Treatment Interruption
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Jan 2013
- Phase
- Phase 1
- 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
- Cohort 1 Only:
- Patients who have been on two more HAART regimens and have failed due to resistance or tolerance (no changes to treatment within 4 weeks of study entry), and who have no viable treatment options likely to result in complete viral suppression.
- CD4+ T cell count of ≥200 cells/mm3
- HIV-1 RNA ≥2000 copies/mL obtained within 60 days prior to study entry performed with an ultrasensitive HIV-1 PCR assay.
- Two HIV-1 RNA levels <150,000 copies/mL obtained within 60 days prior to study entry performed with an ultrasensitive HIV-1 PCR assay. These HIV-1 RNA measurements must be at least 48 hours apart and may include the HIV-1 RNA measurement done at the time of the screening visit.
- Ongoing treatment with HIV entry inhibitors such as enfurvitide or maraviroc are excluded
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- Cohort 2 Only:
- On a stable antiretroviral medication (no changes to treatment within 4 weeks of study entry) and be willing to continue on current antiretroviral therapy for the duration of the study until undergoing structured treatment interruption.
- CD4+ T cell count of ≥450 cells/mm3 at screen; and a documented CD4 nadir of not lower than 300 cells/mm.
- HIV-1 RNA undetectable by ultrasensitive HIV PCR assay obtained within 60 days prior to study entry performed with an ultrasensitive HIV-1 PCR assay.
- Cohort 3 only:
- On a stable antiretroviral medication (no changes to treatment within 4 weeks of study entry) and be willing to continue on current antiretroviral therapy for the duration of the study.
- CD4+ T cell count that is persistently <500 cells/mm3 despite at least 2 years of stable HAART and >200 cells/mm3 at screen
- Subjects must have received at least 2 continuous years of therapy and have had undetectable viral loads by ultrasensitive assay since 6 months of therapy. Subjects who have had a single viral load blip at any point in this time, or who experience intermittent isolated episodes of detectable low-level viremia (detectable but <1000 copies RNA/mL; blips) will remain eligible.
- Subjects who are currently taking maraviroc or have received maraviroc within 6 months of study entry are excluded.
- HIV-1 infection, as documented by ELISA and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
- Adequate venous access and no other contraindications for leukapheresis.
- Laboratory values obtained at screen. Hemoglobin: ≥ 10.0 (males); ≥ 9.5 (females) g/dL Absolute neutrophil count (ANC): ≥ 1000/mm3 Platelet count: ≥ 100,000/mm3 Serum creatinine: ≤ 1.5 mg/dL (133µ mol/L) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT): ≤ 2.5 times the upper limit of normal (ULN).
- Subjects must be willing to comply with study-mandated evaluations; including not changing their antiretroviral regimen (unless medically indicated) for 2 months in step 2 (Cohort 1) or until undergoing structured treatment interruption (Cohort 2).
- Karnofsky Performance Score of 70 or higher
Who cannot join
- Acute or chronic hepatitis B or hepatitis C infection
- Current or prior AIDS diagnosis (Cohort 1 and 2 only)
- History of cancer or malignancy, (basal cell or squamous cell carcinoma of the skin allowed)
- History or problems with uncontrolled heart disease, bleeding or hemodynamic instability.
- Have been previously treated with any HIV experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector.
- Use of the following medications within the last 30 days: chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g., interleukin-2, interferon-alpha or gamma, granulocyte colony stimulating factors, etc.)
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- Breast-feeding, pregnant, or unwilling to use acceptable methods of birth control.
- Use of aspirin, dyprydamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2-week period prior to leukapheresis.
- Active drug or alcohol use or dependence that in the opinion of the investigator, would interfere with adherence to study requirements
- Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry.
- Receipt of a vaccination within 30 days prior to study entry.
- Have an allergy or hypersensitivity to study product excipients (human serum albumin, DMSO and Dextran 40).
- Currently taking medications called HIV entry inhibitors such as enfuvirtide or maraviroc
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jacobi Medical Cener
The Bronx, New York, 10461
About this study
Official title: A Phase I Study of Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 in HIV-Infected Patients
This research study is being carried out to study a new way to possibly treat HIV. This agent is called a "Zinc Finger Nuclease" or ZFN for short. ZFNs are proteins that can delete another protein named CCR5. This CCR5 protein is required for certain common types of HIV (CCR5 tropic) to enter into and infect T-cells. T-cells are one of the white blood cells used by the body to fight HIV. The most important T-cells are those called "CD4 T-cells."
Some people are born without CCR5 on their T-cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 on their T-cells, and their HIV disease is less severe and is slower to cause disease (AIDS).
Read more
In order to delete the CCR5 protein on the T cells, this study will isolate large numbers of T-cells from subjects, and then deliver the ZFNs using a delivery vehicle called a viral vector. The viral vector used in this study is called an adenoviral vector. The vector is added to the cells at the beginning of the manufacture process and the ZFNs knock out the CCR5 protein. By the time T-cells are returned to subjects, there is minimal adenovirus or ZFN present. The removal of the CCR5 protein on the T-cells subjects receive, however, is permanent.
The purpose of this research study is to find out whether "zinc finger" modified T-cells are
- safe to give to humans and
- find how "zinc finger" modified T cell affects HIV
This is an experimental study. Laboratory studies have shown that when CD4 T-cells are modified with "zinc fingers", HIV is prevented from killing the CD4 T cells. On the basis of these laboratory results, there is the potential that "zinc fingers" may work in humans infected with HIV and improve their immune system by allowing their CD4 T-cells to survive longer (HIV usually kills T cells it infects).
All subjects who receive ZFN Modified CD4+T cells will enroll in a Long Term, Follow-up study to monitor subjects. Subjects will be followed every 3 months for four years. If the ZFN Modified CD4+T cells are no longer found in the blood after four years, then subjects will be contacted yearly for the next 6 years. If the ZFN Modified CD4+T cells are found in the blood at year four, then the subjects will continue to be seen once a year until the ZFN Modified CD4+T cells are no longer found in the blood for a maximum of 10 years.
Read the detailed description
Cohort 1 - Patients who have failed two more HAART regimens (6 subjects)
Cohort 2 - Patients doing well on a stable antiretroviral medication (6 subjects)
Cohort 3 - Patients who have an undetectable viral load on HAART who have exhibited suboptimal CD4+ T cell gains during long term antiretroviral therapy. This group will not participate in the structured treatment interruption. (6 subjects)
- Eligibility: Physical Exam, Medical History, Blood Draws for clinical labs and research.
- 1st Procedure to collect T cells (called apheresis)
- 2nd Procedure to collect T cells (called apheresis occurs ~3 weeks after 1st Apheresis)and Rectal Biopsy
- Clinic visit: Physical Exam, Blood Draw for clinical labs and research (~1 to 2 weeks after 2nd Apheresis)
- Infusion of ZFN modified T cells (~2weeks after Clinic Visit) Cohort 1 and Cohort 3 only:
- Follow up Clinic Visits 48, 72 hours; 1,2,3,6 weeks; 2,3,6, 9 months after ZFN infusion.
Cohort 2 Only:
- Stop Antiretroviral Medications 4 Weeks after ZFN modified T cell Infusion.
- Follow-up Clinic Visits 6, 8, 10, 12, 16, weeks after ZFN modified T cell Infusion.
- Restart Antiretroviral Medications 20 weeks after ZFN modified T cell Infusion.
- Follow-up Clinic Visits: monthly visits until no detectable HIV found in blood.
- Conditions
- HIV, HIV Infections
- Being tested
- ZFN modified T cells, Structured Treatment Interruption
- Keywords
- HIV, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZFN modified T cellsBiological
A single infusion of 5-10 billion ZFN Modified CD4+ T Cells
Structured Treatment InterruptionOther
Stop Taking HAART Medication for up to 12 weeks (4 weeks after infusion to 16 weeks after infusion)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients who have failed two more HAART regimens Receives: Biological: ZFN modified T cells |
| Cohort 2 | Experimental | Patients doing well on a stable antiretroviral medication Receives: Biological: ZFN modified T cells; Other: Structured Treatment Interruption |
| Cohort 3 | Experimental | Patients who have an undetectable viral load on HAART who have exhibited suboptimal CD4+ T cell gains during long term antiretroviral therapy. This group will not participate in the structured treatment interruption. Receives: Biological: ZFN modified T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Treatment related adverse events
Measured: Cohort 1, Cohort 3 approximately 1 year from screening. Cohort 2 approximately 40 weeks from screening
Secondary outcomes (7)
Compare the percent of CD4+ and CD8+ T cells that secrete cytokines as a response to stimulation by HIV-specific antigens after the infusion of αCCR5 ZFN-modified autologous T cells
Measured: 8 weeks after the infusion of αCCR5 ZFN-modified autologous T cells
Compare the CD4+ and CD8+ T cells response following stimulation by HIVspecific antigens, at baseline and 8 weeks after the infusion of CCR5 ZFN-modified autologous T cells.
Measured: 8 weeks after the infusion of CCR5 ZFN-modified autologous T cells
To evaluate the change between baseline CD4+ T-cell count and the average of two consecutive CD4+ T-cell count values after dosing and just prior to initiation of a new drug regimen or at weeks 8 and 12, whichever comes first.
Measured: week 8 or 12
Cohort 1: To evaluate the change between baseline log10 HIV-1 RNA level and the average of two consecutive viral load measurements of log10 HIV-1 RNA levels after dosing.
Measured: weeks 8 and 12
Cohort 2: To evaluate the time to recrudescence to >500 copies/ml viral load, and viral set point following STI as defined by the average of week 12 and 16 readings (week 8 and 12 post STI).
Measured: Week 8 and Week 12
To examine the persistence of CCR5 ZFN-modified autologous T cells in peripheral blood and gut mucosae.
Measured: Cohort 1,3: Week 6 and Month 9. Cohort 2: Day 21, Week 16
To monitor for viral drift from CCR5 to CXCR4 trophic virus post treatment using the Monogram Trofile assay, and change in genotypic viral resistance profile using the Monogram GenSeq assay.
Measured: Cohort 2 only: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Sangamo Therapeutics
- Responsible party
- Sponsor
- Investigators
- Pablo Tebas, MD, Principal investigator, University of PennsylvaniaDavid Stein, MD, Principal investigator, Jacobi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842634
- Sponsor's protocol ID
- 806383
- Acronym
- Zinc-Finger
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2009
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tebas P, Stein D, Tang WW, Frank I, Wang SQ, Lee G, Spratt SK, Surosky RT, Giedlin MA, Nichol G, Holmes MC, Gregory PD, Ando DG, Kalos M, Collman RG, Binder-Scholl G, Plesa G, Hwang WT, Levine BL, June CH. Gene editing of CCR5 in autologous CD4 T cells of persons infected with HIV. N Engl J Med. 2014 Mar 6;370(10):901-10. doi: 10.1056/NEJMoa1300662.
PubMed 24597865
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 in HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00842634
- Acronym / sponsor ID
- Zinc-Finger / 806383
- Conditions
- HIV, HIV Infections
- Keywords
- HIV, Treatment Experienced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Sangamo Therapeutics
- Study start
- Jan 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Feb 2009 (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 research study is being carried out to study a new way to possibly treat HIV. This agent is called a "Zinc Finger Nuclease" or ZFN for short. ZFNs are proteins that can delete another protein named CCR5. This CCR5 protein is required for certain common types of HIV (CCR5 tropic) to enter into and infect T-cells. T-cells are one of the white blood cells used by the body to fight HIV. The most important T-cells are those called "CD4 T-cells."
Some people are born without CCR5 on their T-cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 on their T-cells, and their HIV disease is less severe and is slower to cause disease (AIDS).
In order to delete the CCR5 protein on the T cells, this study will isolate large numbers of T-cells from subjects, and then deliver the ZFNs using a delivery vehicle called a viral vector. The viral vector used in this study is called an adenoviral vector. The vector is added to the cells at the beginning of the manufacture process and the ZFNs knock out the CCR5 protein. By the time T-cells are returned to subjects, there is minimal adenovirus or ZFN present. The removal of the CCR5 protein on the T-cells subjects receive, however, is permanent.
The purpose of this research study is to find out whether "zinc finger" modified T-cells are
- safe to give to humans and
- find how "zinc finger" modified T cell affects HIV
This is an experimental study. Laboratory studies have shown that when CD4 T-cells are modified with "zinc fingers", HIV is prevented from killing the CD4 T cells. On the basis of these laboratory results, there is the potential that "zinc fingers" may work in humans infected with HIV and improve their immune system by allowing their CD4 T-cells to survive longer (HIV usually kills T cells it infects).
All subjects who receive ZFN Modified CD4+T cells will enroll in a Long Term, Follow-up study to monitor subjects. Subjects will be followed every 3 months for four years. If the ZFN Modified CD4+T cells are no longer found in the blood after four years, then subjects will be contacted yearly for the next 6 years. If the ZFN Modified CD4+T cells are found in the blood at year four, then the subjects will continue to be seen once a year until the ZFN Modified CD4+T cells are no longer found in the blood for a maximum of 10 years.
Detailed description
Cohort 1 - Patients who have failed two more HAART regimens (6 subjects)
Cohort 2 - Patients doing well on a stable antiretroviral medication (6 subjects)
Cohort 3 - Patients who have an undetectable viral load on HAART who have exhibited suboptimal CD4+ T cell gains during long term antiretroviral therapy. This group will not participate in the structured treatment interruption. (6 subjects)
- Eligibility: Physical Exam, Medical History, Blood Draws for clinical labs and research.
- 1st Procedure to collect T cells (called apheresis)
- 2nd Procedure to collect T cells (called apheresis occurs ~3 weeks after 1st Apheresis)and Rectal Biopsy
- Clinic visit: Physical Exam, Blood Draw for clinical labs and research (~1 to 2 weeks after 2nd Apheresis)
- Infusion of ZFN modified T cells (~2weeks after Clinic Visit) Cohort 1 and Cohort 3 only:
- Follow up Clinic Visits 48, 72 hours; 1,2,3,6 weeks; 2,3,6, 9 months after ZFN infusion.
Cohort 2 Only:
- Stop Antiretroviral Medications 4 Weeks after ZFN modified T cell Infusion.
- Follow-up Clinic Visits 6, 8, 10, 12, 16, weeks after ZFN modified T cell Infusion.
- Restart Antiretroviral Medications 20 weeks after ZFN modified T cell Infusion.
- Follow-up Clinic Visits: monthly visits until no detectable HIV found in blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: ZFN modified T cellsPatients who have failed two more HAART regimens |
| Cohort 2 | Experimental | Biological: ZFN modified T cells, Other: Structured Treatment InterruptionPatients doing well on a stable antiretroviral medication |
| Cohort 3 | Experimental | Biological: ZFN modified T cellsPatients who have an undetectable viral load on HAART who have exhibited suboptimal CD4+ T cell gains during long term antiretroviral therapy. This group will not participate in the structured treatment interruption. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients who have been on two more HAART regimens and have failed due to resistance or tolerance (no changes to treatment within 4 weeks of study entry), and who have no viable treatment options likely to result in complete viral suppression.
- CD4+ T cell count of ≥200 cells/mm3
- HIV-1 RNA ≥2000 copies/mL obtained within 60 days prior to study entry performed with an ultrasensitive HIV-1 PCR assay.
- Two HIV-1 RNA levels <150,000 copies/mL obtained within 60 days prior to study entry performed with an ultrasensitive HIV-1 PCR assay. These HIV-1 RNA measurements must be at least 48 hours apart and may include the HIV-1 RNA measurement done at the time of the screening visit.
- Ongoing treatment with HIV entry inhibitors such as enfurvitide or maraviroc are excluded
Key exclusion criteria (13 listed)
- Acute or chronic hepatitis B or hepatitis C infection
- Current or prior AIDS diagnosis (Cohort 1 and 2 only)
- History of cancer or malignancy, (basal cell or squamous cell carcinoma of the skin allowed)
- History or problems with uncontrolled heart disease, bleeding or hemodynamic instability.
- Have been previously treated with any HIV experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector.
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 |
|---|---|---|
| ZFN modified T cellsA single infusion of 5-10 billion ZFN Modified CD4+ T Cells | Biological | Cohort 1, Cohort 2, Cohort 3 |
| Structured Treatment InterruptionStop Taking HAART Medication for up to 12 weeks (4 weeks after infusion to 16 weeks after infusion) | Other | Cohort 2 |
Primary outcome
Safety - Treatment related adverse events
Time frame: Cohort 1, Cohort 3 approximately 1 year from screening. Cohort 2 approximately 40 weeks from screening
7 secondary outcomes
Compare the percent of CD4+ and CD8+ T cells that secrete cytokines as a response to stimulation by HIV-specific antigens after the infusion of αCCR5 ZFN-modified autologous T cells
Time frame: 8 weeks after the infusion of αCCR5 ZFN-modified autologous T cells
Compare the CD4+ and CD8+ T cells response following stimulation by HIVspecific antigens, at baseline and 8 weeks after the infusion of CCR5 ZFN-modified autologous T cells.
Time frame: 8 weeks after the infusion of CCR5 ZFN-modified autologous T cells
To evaluate the change between baseline CD4+ T-cell count and the average of two consecutive CD4+ T-cell count values after dosing and just prior to initiation of a new drug regimen or at weeks 8 and 12, whichever comes first.
Time frame: week 8 or 12
Cohort 1: To evaluate the change between baseline log10 HIV-1 RNA level and the average of two consecutive viral load measurements of log10 HIV-1 RNA levels after dosing.
Time frame: weeks 8 and 12
Cohort 2: To evaluate the time to recrudescence to >500 copies/ml viral load, and viral set point following STI as defined by the average of week 12 and 16 readings (week 8 and 12 post STI).
Time frame: Week 8 and Week 12
To examine the persistence of CCR5 ZFN-modified autologous T cells in peripheral blood and gut mucosae.
Time frame: Cohort 1,3: Week 6 and Month 9. Cohort 2: Day 21, Week 16
To monitor for viral drift from CCR5 to CXCR4 trophic virus post treatment using the Monogram Trofile assay, and change in genotypic viral resistance profile using the Monogram GenSeq assay.
Time frame: Cohort 2 only: Week 16
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 8 Feb 2019.
- Derived from this study: PubMed 24597865Tebas P, Stein D, Tang WW, Frank I, Wang SQ, Lee G, Spratt SK, Surosky RT, Giedlin MA, Nichol G, Holmes MC, Gregory PD, Ando DG, Kalos M, Collman RG, Binder-Scholl G, Plesa G, Hwang WT, Levine BL, June CH. Gene editing of CCR5 in autologous CD4 T cells of persons infected with HIV. N Engl J Med. 2014 Mar 6;370(10):901-10. doi: 10.1056/NEJMoa1300662.
- Clinical Trials Listing for UPENN HIV Clinical Trials UnitLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Pablo Tebas, MD principal investigator
University of Pennsylvania
David Stein, MD principal investigator
Jacobi Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZFN modified T cells and Structured Treatment Interruption in people with HIV and HIV Infections, run by University of Pennsylvania 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 20 inclusion and 13 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 8 Feb 2019. 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 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.
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?
Safety - Treatment related adverse events (time frame: Cohort 1, Cohort 3 approximately 1 year from screening. Cohort 2 approximately 40 weeks from screening). 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 NCT00842634, which also lists 1 linked publication.
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 Feb 2019.