Long Term Follow up for the Detection of Delayed Adverse Events in Cal-1 Recipients
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ClinicalTrials.gov Identifier: NCT02390297 |
Recruitment Status :
Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : February 4, 2021
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Condition or disease | Intervention/treatment |
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HIV-1 Infection Receipt of Cal-1 Modified Hematopoietic Cellular Products | Genetic: Blood tests |
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 |
Group/Cohort | Intervention/treatment |
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Single
Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses
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Genetic: Blood tests
Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses |
- Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures [ Time Frame: 15 years ]
- 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

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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 |
Inclusion Criteria:
- Signed informed consent
- Previous treatment with the Cal-1 modified hematopoietic cellular products
Exclusion Criteria:
- Inability to understand and provide informed consent

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
United States, California | |
UCLA CARE Center | |
Los Angeles, California, United States, 90035 | |
Quest Clinical Research | |
San Francisco, California, United States, 94115 |
Principal Investigator: | Ronald Mitsuyasu, MD | University of California, Los Angeles |
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: | February 4, 2021 |
Last Verified: | February 2021 |