Study on Interleukin-7 (CYT107) in HIV Patients (Inspire 2)
This study will evaluate the biological activity and pharmacokinetics of 20µg/kg/week of Interleukin-7 (CYT107).
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Pharmacokinetics of the first and third cycle will be accurately studied over 12 hours and then the following 24, 48 and 96 hours. For each patient, the individuals concentration in pg/ml will be evaluated [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|Experimental: CYT107 (r-hIL-7)||
20 µg/kg/week. 3 administrations, 1 per week
Other Name: CYT107
This is a phase IIa study assessing weekly doses of CYT107 in addition to antiviral treatment in adult patients with HIV.
Study patients will receive a subcutaneous administration of CYT107 per week for a total of 3 weeks.
12 patients will be included in the study for a duration of approximately 1 year. During the study patients will continue their usual antiretroviral treatment.
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
- Urine tests several times during the study.
|United States, Florida|
|University of Miami School of Medicine|
|Miami, Florida, United States, 33136|
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|McGill University Health Center (MUHC)|
|Montreal, Quebec, Canada, H2X 2P4|
|Study Chair:||Michael M. Lederman,, Pr||Case Western Reserve University|