Dose Escalation Study of Cyclophosphamide in HIV-Infected Subjects on HAART Receiving SB-728-T

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2017-07-07

Brief Summary

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The purpose of the study is to evaluate the safety, tolerability and effect on HIV viral load, of escalating doses of cyclophosphamide administered 1 day prior to SB-728-T infusion.

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Detailed Description

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The objectives of the study are to augment HIV-specific T-cells and to reverse or decrease the progressive destruction of CD4+ T-cells that leads to clinical AIDS. Levels of engraftment vary from negligible to about 10% of the CD4+ T-cells in the vascular compartment. Preliminary analyses of HAART TI suggest that an anti-HIV effect may correlate with the level of SB-728-T engraftment. Concurrently, non-myeloablative lymphodepletion with cyclophosphamide has been demonstrated to enhance engraftment of adoptively transferred T-cells through a variety of mechanisms. The study is being undertaken to increase SB-728-T engraftment through the administration of low non-myeloablative doses of cyclophosphamide.

Conditions

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HIV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1 - IV cyclophosphamide 200 mg

Group Type EXPERIMENTAL

SB-728-T

Intervention Type GENETIC

Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg

Cohort 2 - IV cyclophosphamide 0.5 g/m2

Group Type EXPERIMENTAL

SB-728-T

Intervention Type GENETIC

Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2

Cohort 3 - IV cyclophosphamide 1.0 g/m2

Group Type EXPERIMENTAL

SB-728-T

Intervention Type GENETIC

Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2

Cohort 4 - IV cyclophosphamide 2.0 g/m2

Group Type EXPERIMENTAL

SB-728-T

Intervention Type GENETIC

Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2

Cohort 5 - IV cyclophosphamide 1.5 g/m2

Group Type EXPERIMENTAL

SB-728-T

Intervention Type GENETIC

Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2

Interventions

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SB-728-T

Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg

Intervention Type GENETIC

SB-728-T

Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2

Intervention Type GENETIC

SB-728-T

Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2

Intervention Type GENETIC

SB-728-T

Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2

Intervention Type GENETIC

SB-728-T

Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2

Intervention Type GENETIC

Other Intervention Names

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cyclophosphamide cyclophosphamide cyclophosphamide cyclophosphamide cyclophosphamide

Eligibility Criteria

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Inclusion Criteria

* Male or female, 18 years of age or older with documented HIV diagnosis within 10 years of screening.
* Must be willing to comply with study-mandated evaluations; including discontinuation of current antiretroviral therapy during the treatment interruption.
* Must have received at least 6 months of continuous HAART therapy and have had undetectable VLs for the preceding 3 months.
* On stable antiretroviral medication (no changes to treatment within 4 weeks of screening.
* CD4+ T-cell count ≥500 cells/µL.
* Undetectable HIV-1 RNA obtained at screening.
* ANC ≥2500/µL
* Platelet count ≥200,000/µL

Exclusion Criteria

* Acute or chronic hepatitis B or hepatitis C infection.
* Active or recent (in prior 6 months) AIDS defining complication.
* Any cancer or malignancy within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin or low grade (0 or 1) anal or cervical dysplasia.
* Current diagnosis of NYHA grade 3 or 4 CHF, uncontrolled angina or arrhythmias.
* History or any features on physical examination indicative of a bleeding diathesis.
* Received HIV experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector.
* Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents within 30 days prior to screening.
* Use of Aspirin, dipyridamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2 week period prior to leukapheresis.
* Currently participating in another clinical trial or participation in such a trial within 30 days prior to screening visit.
* Subjects who are currently taking maraviroc or have received maraviroc within 6 months prior to screening.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No