NCT01241643

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Cytheris SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	CYT107	repeated cycles of 3 injections 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

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2010-11-16
• Last updated: 2013-07-25

Locations

3 sites across 3 countries: Italy, South Africa, Switzerland