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.

Cytheris SA3 sites in 3 countries92 target enrollmentSeptember 2010

ConditionsHIV

InterventionsCYT107

DrugsCYT107

Overview

Phase: Phase 2
Intervention: CYT107
Conditions: HIV
Sponsor: Cytheris SA
Enrollment: 92
Locations: 3
Primary Endpoint: 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.
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

June 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cytheris SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•HIV-1 infection as documented by any licensed ELISA (Enzyme-Linked Immunosorbent Assay) test kit and confirmed either by Western Blot or a 2nd test using a different method at any time prior to study entry
•On HAART (Highly active anti-retroviral therapy) for at least 24 months, on stable regimen for at least 6 months prior to study entry. HAART is defined as a combination of two (2) classes dose regimen of approved ARV (antiretroviral)
•CD4+ cell counts ≥ 101 and \< 350 cells/µL measured on at least two (2) measurements (including the screening value) within the previous 12 months prior to study entry Note: a single isolated value of CD4+ ≥ 350 during this period (12 months prior to study entry) will be allowed to participate if the previous and subsequent CD4+ count is in the range of ≥ 101 and \< 350 cells/µL
•Plasma HIV RNA \< 50 copies/mL since at least 18 months with at least two (2) measurements (including the screening value) within the previous 6 months prior study entry Note: patients with single blip of detectable viremia during this period (6 months prior to study entry) will be allowed to participate if the prior and subsequent plasma HIV RNA levels are \< 50 copies/mL
•Adequate bone marrow, hepatic and renal function as follows:
•Hemoglobin ≥ 10 g/dl
•Neutrophils ≥ 1,000/µL
•Platelets ≥ 100,000/µL
•AST, ALT, or Alk. Phosph. ≤ 2.5 x ULN
•Total Bilirubin ≤ 1.5 x ULN (or ≤ 5 x ULN if the patient is treated by atazanavir or by indinavir, and if the increase is due to unconjugated bilirubin and if ALT and AST are normal)

Exclusion Criteria

•AIDS-defining illness (category C) diagnosed within the last 12 months prior to study entry
•History of HIV related encephalopathy
•Active opportunistic infection including active tuberculosis
•Previous treatment with IL-2 or IL-7 at any time prior to study entry
•Any planned or probable modification of the anti-retroviral treatment during the first year or the first two cycles of CYT107 Note: in case of product shortage and in absence of viral mutation suspicion or viral blip, a modification of ARV will not be an exclusion criterion
•Poor compliance on HAART or any other chronic treatment that in the opinion of the investigator will interfere with protocol participation
•Previous treatment with immuno-modulatory agents such as, systemic corticosteroids, growth factors, immunosuppressive drugs, HIV vaccine, or anti-cancer treatment or hydroxyurea within 3 months prior to study entry
•Any history of malignancy (except basal carcinoma of the skin) including any hematologic malignancy or AIDS defining malignancy, such as lymphoproliferative disorder or Kaposi's sarcoma Note: Patients with Kaposi's sarcoma limited to the skin that had disappeared while on HAART therapy, and without requiring any other systemic therapy 1 year prior to study entry, will be eligible.
•Any history of severe auto-immune disease requiring systemic treatment or hospitalization, or any active auto-immune disease requiring treatment (including multiple sclerosis)
•History of splenectomy

Arms & Interventions

CYT107

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

Intervention: CYT107

Outcomes

Primary Outcomes

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.

Time Frame: 24 months

Secondary Outcomes

To characterize CYT107 Pharmacokinetics (PK) / Pharmacodynamics (PD)(24 months)
To characterize the key immuno-pharmacological effects(24 months)
To assess CYT107 effect on HIV-induced chronic systemic immune hyper-activation and its consequences(24 months)