Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T
Information provided by (Responsible Party)
First received: December 13, 2019
Last updated: July 15, 2020
Last Verified: October 2019
History of Changes
Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T in a previous trial and completed 3 years of post-infusion follow-up. Enrolling subjects will be followed for a total of 12 years.
Drug : There are no disallowed treatments
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
|Official Title:||Long-Term Follow-up of HIV-Infected Subjects Treated With Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases (SB-728-T or SB-728mR-T)|
Further study details as provided by Sangamo Therapeutics:
Primary Outcome Measures
Long-term safety of treatment with SB-728-T or SB-728mR-T
[ Time Frame: 12 years ]
Number of subjects with delayed adverse events associated with administration of SB-728-T or SB-728mR-T, autologous T-cells genetically modified at the CCR5 gene by zinc finger nucleases.
- Long-term persistence of SB-728-T or SB-728mR-T
[ Time Frame: 2 years ]
Long-term persistence of SB-728-T or SB-728mR-T will be measured by serial measurement of CCR5 gene modification.
- Change in HIV reservoirs [ Time Frame: 2 years ]
Change in HIV reservoirs will be measured by serial measurement of HIV-1 RNA, HIV proviral DNA and HIV Co-receptor Tropism
|Study Start Date:||March 18, 2011|
|Estimated Study Completion Date:||December 31, 2031|
|Estimated Primary Completion Date:||December 31, 2031 (Final data collection date for primary outcome measure)|
Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T in a previous trial.
There are no disallowed treatments
Genetic: SB-728-T or SB-728mR-T No study drug is administered in this study. Subjects who received SB-728-T or SB-728mR-T in a previous trial will be evaluated in this trial for long-term safety and efficacy.
Subjects infected with HIV who have received therapy with SB-728-T or SB-728mR-T and have
completed 3 years of post-infusion follow-up will be eligible to participate in this trial.
There will be no treatment in this long-term follow-up study. Subjects who choose to enroll
into this extension study will be evaluated for a total of 12 years.
An optional leukapheresis may be performed upon sponsor request.
|Ages Eligible for Study:||Child, Adult, Senior|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Subjects who have, in previous Sangamo clinical trial received SB-728-T or SB-728mR-T, autologous T-cells genetically modified at the CCR5 gene by zinc finger nucleases, have completed 3 years of post-infusion follow-up, and give consent to participate in the long-term follow-up study.
There are no exclusion criteria for this study.
Contacts and LocationsChoosing 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: NCT04201782
Locations Show More
|United States, California|
|Quest Clinical Research|
|San Francisco, California, United States, 94115|
|United States, Connecticut|
|Circle CARE Center, LLC|
|Norwalk, Connecticut, United States, 06850|
|United States, Florida|
|Orlando Immunology Center|
|Orlando, Florida, United States, 32803|
|United States, New Mexico|
|Southwest CARE Center|
|Santa Fe, New Mexico, United States, 87505|
|United States, Texas|
|Central Texas Clinical Research|
|Austin, Texas, United States, 78705|
Sponsors and CollaboratorsSangamo Therapeutics
|Study Director:||Medical Monitor||Sangamo Therapeutics, Inc.|
|Responsible Party:||Sangamo Therapeutics|
|ClinicalTrials.gov Identifier:||NCT04201782 History of Changes|
|Other Study ID Numbers:||SB-728-1003|
|Study First Received:||December 13, 2019|
|Last Updated:||July 15, 2020|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Keywords provided by Sangamo Therapeutics:HIV
ClinicalTrials.gov processed this data on August 07, 2020
This information is provided by ClinicalTrials.gov.