Study on Interleukin-7 (CYT107) in HIV Patients — Inspire 2  

HIV Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

• NCT number: NCT01190111
• Study type: Interventional
• Source: Cytheris SA
• Status: Terminated
• Phase: Phase 2
• Start date: January 2010
• Completion date: June 2013