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

Completed · Phase 1/Phase 2

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT01543152

Run by

Sangamo Therapeutics

People needed

26

Starts

2011-12-01

Expected to finish

2017-07-07

Last updated by the study team

2021-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UCLA Care Center — Los Angeles, California, United States
• Quest Clinical Research — San Francisco, California, United States
• Circle CARE Center, LLC — Norwalk, Connecticut, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Central West Clinical Research, Inc. — St Louis, Missouri, United States
• Southwest CARE Center — Santa Fe, New Mexico, United States
• Ricky K Hsu, MD, PC — New York, New York, United States
• Central Texas Clinical Research — Austin, Texas, United States
• North Texas Infectious Diseases Consultants — Dallas, Texas, United States
• Gordon Crofoot, MD, PA — Houston, Texas, United States
• Clinical Research Puerto Rico — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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