Long Term Follow up for the Detection of Delayed Adverse Events in Cal-1 Recipients
Active, not recruiting
- Conditions
- Receipt of Cal-1 Modified Hematopoietic Cellular ProductsHIV-1 Infection
- Registration Number
- NCT02390297
- Lead Sponsor
- Calimmune, Inc.
- Brief Summary
Long term safety follow-up of Cal-1 recipients
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
- Signed informed consent
- Previous treatment with the Cal-1 modified hematopoietic cellular products
Exclusion Criteria
- Inability to understand and provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection of delayed clinical or molecular adverse events related to Cal-1, or the associated delivery procedures 15 years
- Secondary Outcome Measures
Name Time Method 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 15 yars
Trial Locations
- Locations (2)
UCLA CARE Center
🇺🇸Los Angeles, California, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
UCLA CARE Center🇺🇸Los Angeles, California, United States