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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Calimmune, Inc.
ClinicalTrials.gov Identifier:
NCT02390297
First received: March 11, 2015
Last updated: July 26, 2016
Last verified: July 2016
  Purpose
Long term safety follow-up of Cal-1 recipients

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Calimmune, Inc.:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 18
Study Start Date: March 2015
Estimated Study Completion Date: January 2032
Estimated Primary Completion Date: January 2031 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02390297

Locations
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
Principal Investigator: Ronald Mitsuyasu, MD University of California, Los Angeles
  More Information

Responsible Party: Calimmune, Inc.
ClinicalTrials.gov Identifier: NCT02390297     History of Changes
Other Study ID Numbers: CAL-INT-00
Study First Received: March 11, 2015
Last Updated: July 26, 2016

ClinicalTrials.gov processed this record on July 26, 2017