Study on Interleukin-7 (CYT107) in HIV Patients (Inspire 2)
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|ClinicalTrials.gov Identifier: NCT01190111|
Recruitment Status : Terminated (CYTHERISSA filed for banckcuptcy in June 2013.Subjects treated by CYT 107 were followed up for at the least 3 months.)
First Posted : August 27, 2010
Last Update Posted : August 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV||Biological: Interleukin-7||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
|Experimental: CYT107 (r-hIL-7)||
20 µg/kg/week. 3 administrations, 1 per week (1 cycle) repeated cycles based on a CD4-guided response
Other Name: CYT107
- • To study, in all included patients, 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. [ Time Frame: 2 years (24 months) ]
- • To characterize in the first 12 patients, PK and PD of CYT107 . • To further characterize in all included patients, the safety profile established with CYT107 at 20 µg/kg including monitoring of HIV RNA and immunogenicity. • • • [ Time Frame: 2 years ]
- To characterize in the first 12 patients, PK and PD of CYT107 .
- To further characterize, the safety profile established with CYT107 at 20 µg/kg including monitoring of HIV RNA and immunogenicity.
- To further examine CYT107 effect on HIV specific T-cells.
- To document other properties of IL-7, (ie: T-cell homing within the GI tract).
To assess the sustained CD4 increase until the end of the two years
- the safety of CYT107 treatment over the same period
- the potential effect of the CYT107 induced immune reconstitution on HIV-induced chronic systemic immune hyper-activation and its consequences
- clinical and lab assessment Imaging, EKG and Ultrasound IL-7 Pharmacokinetics and Immunogenicity IL-7 Pharmacodynamics/Immunology Bacterial Translocation and HLA typing [ Time Frame: every 3 months up to the end of study period 2years ]
Immune Monitoring will consist on T-cell subsets identification and quantification (such as RTE, naïve/effector and memory CD4 and CD8 T-cells, B cells, CD4 CD25 Fox P3 regulatory T-cells), quantification of the expression of CD127 and the evaluation of T-cell cycling and survival.
T-cell Repertoire Diversity:
Thymopoiesis Evaluation: Quantification of sjTRECs and βTRECs will be done by Real Time Quantitative PCR, and Ratio values will be analyzed.
GUT Biopsy - T-cell Homing :Essential receptors expression for intestinal homing, namely the integrin α4β7 and CCR9, the receptor for the gut-associated chemokine TECK/CCL25 could be assessed as well as molecules for T-cell trafficking (CCR7, CXCR4, CXCL12...) in the gut biopsies.
Immunogenicity: antidrug antibody (ADA) and neutralizing ADA will be tested. In case of a positive sample, the test will be repeated every 3 months until negative.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190111
|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|