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Long Term Follow up for the Detection of Delayed Adverse Events in Cal-1 Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02390297
Recruitment Status : Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Calimmune, Inc.

Study Description
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Brief Summary:
Long term safety follow-up of Cal-1 recipients

Condition or disease Intervention/treatment
HIV-1 Infection Receipt of Cal-1 Modified Hematopoietic Cellular Products Genetic: Blood tests

Detailed Description:
Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced with LVsh5/C46 (Cal-1), a Dual Anti-HIV Gene Transfer Construct
Study Design
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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Long Term Follow-up for the Detection of Delayed Adverse Events in Recipients of CD4+ T Lymphocytes and/or CD34+ Hematopoietic Stem/Progenitor Cells Transduced With LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct
Actual Study Start Date : April 2015
Estimated Primary Completion Date : October 2031
Estimated Study Completion Date : October 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort Intervention/treatment
Single
Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses
 Genetic: Blood tests
Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses


Outcome Measures
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Primary Outcome Measures :
  1. Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures [ Time Frame: 15 years ]

Secondary Outcome Measures :
  1. Assessment of the long term survival and activity of Cal-1 modified hematopoietic cells through evaluation of Cal-1 marking and expression in peripheral blood [ Time Frame: 15 yars ]

Biospecimen Retention:   Samples With DNA
Cryopreserved white blood cells and DNA and RNA extracted from peripheral blood

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligibility for this protocol is dependent on prior exposure to a Cal-1 modified hematopoietic cellular product. The study population will thus consist of individuals with HIV-1 infection, who have met criteria for participation in a Cal-1 phase I/II clinical trial and received a dose of Cal-1 modified hematopoietic cells as part of a previous study
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Previous treatment with the Cal-1 modified hematopoietic cellular products

Exclusion Criteria:

  • Inability to understand and provide informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390297


Locations
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United States, California
UCLA CARE Center
Los Angeles, California, United States, 90035
Quest Clinical Research
San Francisco, California, United States, 94115
Sponsors and Collaborators
Calimmune, Inc.
Investigators
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Principal Investigator: Ronald Mitsuyasu, MD University of California, Los Angeles
More Information
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Responsible Party: Calimmune, Inc.
ClinicalTrials.gov Identifier: NCT02390297    
Other Study ID Numbers: CAL-INT-00
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019