This study was designed to evaluate the pharmacokinetics of 20µg/kg/week of Interleukin-7 (CYT107), the biological activity and safety of repeated cycles of CYT107, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months.
This was a phase IIa study assessing weekly doses of CYT107 in addition to antiviral treatment (HAART) in adult patients with HIV. CYT107 were administered at the dose of 20 µg/kg based on the patient's weight, in 3 weekly administrations. CYT107 Subcutaneous injection administered at the clinic or day hospital Patients were followed every 3 months for primary and secondary biological activity criteria as well as safety up to 24 months long term follow-up with quarterly visits. A cycle = 3 weekly administrations; D/d0; D/d7; D/d14 For all patients there will be a maximum of 3 cycles over 12 months and a maximum of 4 cycles over 21 months, for a total duration on study of 24 months. All patients were receiving and continued to receive combination antiretroviral therapy while on-study. Pre-medication was not be used systematically but might be administered if needed according to standard clinical practice. During the study visits the following may be done: * Medical history, physical examination, blood tests every visit. * Electrocardiogram (EKG) * Chest x-ray study * Liver/spleen imaging * Blood sample collections at frequent intervals for laboratory tests (Virology: HIV RNA \&HIV DNA;Pharmacodynamics/Immunology;Bacterial translocation ) * Urine tests several times during the study. PBMCs collections for immunological testing An optional substudy on gut biopsy performed prior and at month 3 after the first CYT107 cycle to evaluate T cell homing
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
20 µg/kg/week. 3 administrations, 1 per week (1 cycle) repeated cycles based on a CD4-guided response
University of Miami School of Medicine
Miami, Florida, United States
Niaid/Nih
Bethesda, Maryland, United States
Case Western Reserve University
Cleveland, Ohio, United States
McGill University Health Center (MUHC)
Montreal, Quebec, Canada
• To study, in all included patients, the biological activity and safety of repeated cycles of CYT107, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months.
Time frame: 2 years (24 months)
• To characterize in the first 12 patients, PK and PD of CYT107 . • To further characterize in all included patients, the safety profile established with CYT107 at 20 µg/kg including monitoring of HIV RNA and immunogenicity. • • •
* To characterize in the first 12 patients, PK and PD of CYT107 . * To further characterize, the safety profile established with CYT107 at 20 µg/kg including monitoring of HIV RNA and immunogenicity. * To further examine CYT107 effect on HIV specific T-cells. * To document other properties of IL-7, (ie: T-cell homing within the GI tract). * To assess the sustained CD4 increase until the end of the two years * the safety of CYT107 treatment over the same period * the potential effect of the CYT107 induced immune reconstitution on HIV-induced chronic systemic immune hyper-activation and its consequences
Time frame: 2 years
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