Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sangamo Therapeutics
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 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 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.
Clareo Health | Dose Escalation Study of Cyclophosphamide in HIV-Infected Subjects on HAART Receiving SB-728-T
