Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T

Terminated

• Conditions: HIV-1-infection
• Interventions: Drug: There are no disallowed treatments

• Registration Number: NCT04201782
• Lead Sponsor: Sangamo Therapeutics

Brief Summary

Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T. Enrolling subjects will be followed for a total of 12 years.

Detailed Description

Subjects infected with HIV who have received therapy with SB-728-T or SB-728mR-T 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.

Study Timeline

• Study Start: 2011-03-18
• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-17
• Primary Completion: 2023-07-17
• Study Completion: 2023-07-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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.

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Exclusion Criteria

There are no exclusion criteria for this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	There are no disallowed treatments	Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T in a previous trial.

Primary Outcome Measures

Name	Time	Method
Long-term safety of treatment with SB-728-T or SB-728mR-T	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.

Secondary Outcome Measures

Name	Time	Method
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.	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

Trial Locations

Locations (4)

Orlando Immunology Center; 🇺🇸 Orlando, Florida, United States

Quest Clinical Research; 🇺🇸 San Francisco, California, United States

Circle CARE Center, LLC; 🇺🇸 Norwalk, Connecticut, United States

Central Texas Clinical Research; 🇺🇸 Austin, Texas, United States