Randomized Study on Multiple Cycles of Interleukin-7 in HIV Patients Immune Non-responders — Inspire 3  

HIV Clinical Trial

Official title: A Multicenter, Open-labeled, Controlled, Randomized Study of Recombinant Interleukin-7 (CYT107) Treatment to Restore and Maintain CD4 T-lymphocyte Counts Above 500 Cells/µL in HIV-infected Patients With CD4 Counts Remaining Between 101-350 Cells/µL After at Least 2 Years of HAART and Plasma HIV RNA < 50 Copies/mL for 18 Months.

Status Terminated

Clinical Trial Summary

This is a Phase II multicenter, open-labeled, controlled, randomized study assessing weekly doses of Interleukin-7 (CYT107)

Clinical Trial Description

The aim of the study is to assess repeated cycles of 3 weekly injections of CYT107 in patients immune non-responders infected with HIV.

Eighty patients will be recruited to study the biological activity and safety of repeated cycles of CYT107 at 20 µg/kg/week over 2 weeks, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months. The entire study will cover a period of 24 months.

During the study visits the following may be done:

• medical history, physical examination, blood test every visit

• EKG

• chest X-Ray

• liver/spleen ultrasound ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

• NCT number: NCT01241643
• Study type: Interventional
• Source: Cytheris SA
• Status: Terminated
• Phase: Phase 2
• Start date: September 2010
• Completion date: June 2013