Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sangamo Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented HIV infection prior to study entry
Must be willing to comply with study-mandated evaluations; including not changing their antiretroviral regimen (unless medically indicated) during the study period.
Cohort 1, 2 and 3 (Enrollment Completed)
Cohort 5:
Must have received HAART therapy, and had undetectable viral loads for at least 1 year.
HIV-1 RNA \< 50 copies/mL obtained within 60 days prior to study entry performed with an ultrasensitive HIV-1 PCR assay.
CD4+ T cell count \>500 cells/mm3
Heterozygous for the CCR5 delta-32 mutation
On stable antiretroviral medication (no changes to treatment within 4 weeks of screening and willing to discontinue current antiretroviral therapy during the structured therapy interruption
Cohort 4
On stable antiretroviral medication (no changes to treatment within 4 weeks of screening and willing to continue on current antiretroviral therapy through week 8 after infusion
CD4+ T cell count \>350 cells/mm3.
HIV-1 \>1,000 copies/mL at screen and not responding to current antiviral therapy (i.e. HIV-RNA plasma levels \> 1000 copies/ml after at least 12 weeks of stable, unchanged ARV therapy).
You may not be 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 uncontrolled arrhythmias.
History or any features on physical examination indicative of a bleeding diathesis.
Previous treatment with any 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 (e.g., interleukin-2, interferon-alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to enrollment
Breast-feeding, pregnant or unwilling to use acceptable methods of birth control for 6 months following the last infusion of SB-728-T cells.
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.
Active drug or alcohol use or dependence
Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry.
Recent vaccination or intercurrent illness (within 5 weeks prior to infusion)
Have an allergy or hypersensitivity to study product excipients (human serum albumin, DMSO and Dextran 40).
Subjects who are currently taking maraviroc or have received maraviroc within 6 months prior to screening.
Cohort 4 only:
HIV-1 RNA \>1,000 copies/mL at screen and not responding to current antiviral therapy
