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

Information source: Sangamo Biosciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV

Intervention: SB-728-T (Genetic); SB-728-T (Genetic); SB-728-T (Genetic); SB-728-T (Genetic); SB-728-T (Genetic)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Sangamo Biosciences

Official(s) and/or principal investigator(s):
Winson Tang, M.D., Study Director, Affiliation: Sangamo BioSciences, Inc.

Overall contact:
Donna Bednarski, Email: dbednarski@sangamo.com


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.

Clinical Details

Official title: A Phase I, Open-Label Study to Assess the Effect of Escalating Doses of Cyclophosphamide on the Engraftment of SB-728-T in Aviremic HIV-Infected Subjects on HAART

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Treatment related Adverse Events on subjects who received cyclophosphamide prior to SB-728-T infusion

Secondary outcome:

Effect of escalating doses of cyclophosphamide on SB-728-T engraftment as measured by pentamer PCR

Effect of SB-728-T on plasma HIV-1 RNA levels following HAART interruption

Change in CD4+ T-cell counts in peripheral blood after treatment with SB-728-T

Detailed 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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.

Locations and Contacts

Donna Bednarski, Email: dbednarski@sangamo.com

Clinical Research Puerto Rico, San Juan 00909, Puerto Rico; Completed

UCLA Care Center, Los Angeles, California 90035, United States; Completed

Orange Coast Medical Group, Newport Beach, California 92663, United States; Withdrawn

Quest Clinical Research, San Francisco, California 94115, United States; Recruiting
Grace Gonzaga, LPN, Phone: 415-353-0212, Email: grace@questclinical.com
Jacob Lalezari, MD, Principal Investigator

Circle CARE Center, LLC, Norwalk, Connecticut 06850, United States; Recruiting
Greg Ulrich, RN, Phone: 203-852-9525, Email: gulrich@whcccc.org
Gary Blick, MD, Principal Investigator

Orlando Immunology Center, Orlando, Florida 32803, United States; Recruiting
Jeffrey Garrett, ARNP, Phone: 407-647-3960, Ext: 2151, Email: jgarrett@oicorlando.com
Edwin DeJesus, MD, Principal Investigator

Central West Clinical Research, Inc., St Louis, Missouri 63108, United States; Active, not recruiting

Southwest CARE Center, Santa Fe, New Mexico 87505, United States; Recruiting
Jason Martinez, Phone: 505-216-0318, Email: jmartinez@southwestcare.org
Trevor Hawkins, MD, Principal Investigator

Ricky K Hsu, MD, PC, New York, New York 10011, United States; Recruiting
Monique Carasso, NP, Phone: 212-627-7560, Email: mjcarasso@verizon.net
Ricky K Hsu, MD, PC, Principal Investigator

Central Texas Clinical Research, Austin, Texas 78705, United States; Recruiting
Krissandra Underwood, Phone: 512-480-9660, Email: kunderwood@ctcrcorp.com
David Wright, MD, Principal Investigator

North Texas Infectious Diseases Consultants, Dallas, Texas 75246, United States; Recruiting
Bryan King, Phone: 214-276-5618, Email: bryan.king@ntidc.org
Louis Sloan, MD, Principal Investigator

Gordon Crofoot, MD, PA, Houston, Texas 77098, United States; Completed

Additional Information

Starting date: December 2011
Last updated: July 15, 2015

Page last updated: August 23, 2015

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