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 : December 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection||Drug: There are no disallowed treatments||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||December 31, 2031|
|Estimated Study Completion Date :||December 31, 2031|
Experimental: Cohort 1
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 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
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, New Mexico|
|Southwest CARE Center|
|Santa Fe, New Mexico, United States, 87505|
|United States, Texas|
|Central Texas Clinical Research|
|Austin, Texas, United States, 78705|
|Study Director:||Medical Monitor||Sangamo Therapeutics, Inc.|