Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T
|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: NCT04201782|
Recruitment Status : Enrolling by invitation
First Posted : December 17, 2019
Last Update Posted : April 13, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment|
|HIV-1-infection||Drug: There are no disallowed treatments|
|Study Type :||Observational|
|Estimated Enrollment :||55 participants|
|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)|
|Actual Study Start Date :||March 18, 2011|
|Estimated Primary Completion Date :||June 30, 2035|
|Estimated Study Completion Date :||June 30, 2035|
Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T in a previous trial.
Drug: 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.
- Long-term safety of treatment with SB-728-T or SB-728mR-T [ Time Frame: 12 years ]
Number of subjects with SAEs.
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.
Incidence of new malignancies, neurologic disorders (new or exacerbation of pre-existing), rheumatologic disease (new or exacerbation of pre-existing), autoimmune disorder (new or pre-existing), and new hematologic disorder.
- Long-term effects of SB-728-T or SB-728mR-T on CD4+ T-cell counts and on the viral load and tropism of HIV in blood. [ Time Frame: 2 years ]
Long-term effects of SB-728-T or SB-728mR-T will be measured by the following:
CD4+ T-cell counts through Month 24
HIV co-receptor tropism through Month 24
Viral load through Month 24
Biospecimen Retention: None Retained
- Clinical condition assessment
- Chemistry which includes bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), sodium, potassium, chloride, bicarbonate, urea nitrogen, creatinine, total protein, albumin, calcium, and phosphorous.
- CBC which includes hemoglobin, hematocrit, platelet count, red cell count, and white cell count with differential count
- CD4+ T-cell count
- HIV-1 RNA
- HIV proviral DNA
- Ad5 and SB-728-T immunogenicity
- Research blood
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
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 and give consent to participate in the long-term follow-up study.
There are no exclusion criteria for this study.
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): NCT04201782
|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, Texas|
|Central Texas Clinical Research|
|Austin, Texas, United States, 78705|
|Study Director:||Medical Monitor||Sangamo Therapeutics, Inc.|
|Responsible Party:||Sangamo Therapeutics|
|Other Study ID Numbers:||
|First Posted:||December 17, 2019 Key Record Dates|
|Last Update Posted:||April 13, 2023|
|Last Verified:||April 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|