NCT01190111

Study on Interleukin-7 (CYT107) in HIV Patients

An Open-label, Multicenter Study of Subcutaneous Intermittent Recombinant Interleukin-7 (CYT107) in Chronically HIV-infected Patients With CD4 T-lymphocyte Counts Between 101-400 Cells/mm3 and Plasma HIV RNA< 50 Copies/mL After at Least 12 Months of HAART

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Cytheris SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• HIV

Interventions

Type	Name	Description
BIOLOGICAL	Interleukin-7	20 µg/kg/week. 3 administrations, 1 per week (1 cycle) repeated cycles based on a CD4-guided response

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2010-08-27
• Last updated: 2013-08-01

Locations

4 sites across 2 countries: United States, Canada