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
Summary
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 PCREffect 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
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
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