Trial ID Number: CLI-107-06

Title: A Phase I/IIa Randomized Placebo Controlled, Single-Blind Multicenter Dose-Escalation Study of Subcutaneous Intermittent Interleukin-7 CYT107 in Chronically HIV-Infected Patientswith CD4 T-Lymphocyte Counts Between 101-400 Cells/Mm3 and Plasma HIV RNA< 50 copies/mL after at Least 12 Months of HAART.

Trial Name: INSPIRE (INvestigational Study of Placebo versus IL-7
in haaRt-trEated patients)
Countries: United States, Canada, France and Italy
Status: Ongoing
Link to Clinical Trial: Clinical Trials.Gov

About the INSPIRE HIV Study
The HIV trial (CLI-107-06) is a randomized placebo controlled, single-blind multi-center dose-escalation study of 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 Highly Active Anti-Retroviral Therapy (HAART). The dose escalation scheme is designed to establish the safety of biologically active doses of CYT107, to document the residual CD4 increase achieved at 3 months (“targeted sustained activity”) and to define a dose and schedule for phase II investigation.  In addition, potential biologic Dose Limiting Toxicities (DLT), unique to IL-7 (such as viral reactivation or immunogenicity) will be sought.

Michael M. Lederman, MD, the Scott R. Inkley Professor of Medicine and Director of the Case Western Reserve University/University Hospitals Center for AIDS Research, Cleveland, Ohio, will chair the study along with co-chairs Irini Sereti, MD, US National Institute for Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, and Yves Levy, MD, PhD, Service d’Immunologie Clinique, Hôpital Henri Mondor, Créteil, France. 

Results of two promising Phase I studies of Cytheris’ IL-7 in HIV patients, one conducted by Dr. Levy’s team and the other by the US National Institutes of Health/AIDS Clinical Trials Group (ACTG), were reported at the 2007 Conference on Retroviruses and Opportunistic Infections (CROI) held in Los Angeles. Dr. Levy also presented long-term follow-up results (at week 48) of the French study at the 2008 Conference on Retroviruses and Opportunistic Infections (CROI) held in Boston.