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

NCT ID: NCT04201782

Last Updated: 2024-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-18

Study Completion Date

2023-07-17

Brief Summary

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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

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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.

Conditions

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HIV-1-infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sangamo Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Sangamo Therapeutics, Inc.

Locations

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Quest Clinical Research

San Francisco, California, United States

Site Status

Circle CARE Center, LLC

Norwalk, Connecticut, United States

Site Status

Orlando Immunology Center

Orlando, Florida, United States

Site Status

Central Texas Clinical Research

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SB-728-1003

Identifier Type: -

Identifier Source: org_study_id

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