The Effect of Ixazomib on the Latent HIV Reservoir
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ClinicalTrials.gov Identifier: NCT02946047 |
Recruitment Status :
Completed
First Posted : October 26, 2016
Results First Posted : January 6, 2022
Last Update Posted : January 6, 2022
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Sponsor:
Mayo Clinic
Collaborator:
Takeda
Information provided by (Responsible Party):
Nathan W. Cummins, M.D., Mayo Clinic
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Tracking Information | |||||
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First Submitted Date ICMJE | October 24, 2016 | ||||
First Posted Date ICMJE | October 26, 2016 | ||||
Results First Submitted Date ICMJE | December 8, 2021 | ||||
Results First Posted Date ICMJE | January 6, 2022 | ||||
Last Update Posted Date | January 6, 2022 | ||||
Actual Study Start Date ICMJE | March 20, 2017 | ||||
Actual Primary Completion Date | August 19, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Incidence of Treatment-Emergent Adverse Events [ Time Frame: 7 months ] Number of treatment-emergent adverse events experienced by subjects as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
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Original Primary Outcome Measures ICMJE |
Safety [ Time Frame: 7 months ] Time to complete one dosing regimen of Ixazomib
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | The Effect of Ixazomib on the Latent HIV Reservoir | ||||
Official Title ICMJE | Pilot Study of Ixazomib to Reduce the Number of HIV DNA Positive Lymphoid Cells | ||||
Brief Summary | The primary purpose of the trial is to determine the safety and tolerability of ixazomib in HIV infected patients on antiretroviral therapy. The secondary purpose is to determine the effect of ixazomib on the size of the HIV reservoir. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Human Immunodeficiency Virus (HIV) | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
17 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | August 19, 2019 | ||||
Actual Primary Completion Date | August 19, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02946047 | ||||
Other Study ID Numbers ICMJE | 16-001938 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Nathan W. Cummins, M.D., Mayo Clinic | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Mayo Clinic | ||||
Original Study Sponsor ICMJE | Nathan W. Cummins, M.D. | ||||
Collaborators ICMJE | Takeda | ||||
Investigators ICMJE |
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PRS Account | Mayo Clinic | ||||
Verification Date | December 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |