A Phase 2 interventional study of Interleukin-7 in HIV, sponsored by Cytheris SA. Terminated at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-01.
Sponsored by Cytheris SA · Phase 2, Interventional, and Treatment
This study was designed to evaluate the pharmacokinetics of 20µg/kg/week of Interleukin-7 (CYT107), 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.
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:
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
Cytheris SA is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: Interleukin-7
20 µg/kg/week. 3 administrations, 1 per week (1 cycle) repeated cycles based on a CD4-guided response
Also known as: 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. • • •
* 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
Time frame: 2 years
clinical and lab assessment Imaging, EKG and Ultrasound IL-7 Pharmacokinetics and Immunogenicity IL-7 Pharmacodynamics/Immunology Bacterial Translocation and HLA typing
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.
Time frame: every 3 months up to the end of study period 2years
This study is terminated, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cytheris SA