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

Sangamo Therapeutics

Status and phase

Completed

Phase 2

Phase 1

Conditions

HIV

Treatments

Genetic: SB-728-T

Study type

Interventional

Funder types

Industry

Identifiers

NCT01543152

SB-728-1101

Details and patient eligibility

About

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.

Full description

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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

26 participants in 5 patient groups

Cohort 1 - IV cyclophosphamide 200 mg

Experimental group

Treatment:

Genetic: SB-728-T

Cohort 2 - IV cyclophosphamide 0.5 g/m2

Experimental group

Treatment:

Genetic: SB-728-T

Cohort 3 - IV cyclophosphamide 1.0 g/m2

Experimental group

Treatment:

Genetic: SB-728-T

Cohort 4 - IV cyclophosphamide 2.0 g/m2

Experimental group

Treatment:

Genetic: SB-728-T

Cohort 5 - IV cyclophosphamide 1.5 g/m2

Experimental group

Treatment:

Genetic: SB-728-T

Trial documents

Trial contacts and locations

Data sourced from clinicaltrials.gov

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