HIV infected patients MedDRA version: 9.1 Level: PT Classification code 10020161
Conditions
Sponsors
CYTHERIS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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 2) Age >=18 3) 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) 4) CD4+ cell counts >= 101 and = 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 = 10 g/dl • Neutrophils >= 1,000/?L • Platelets >= 100,000/?L • AST, ALT, or Alk. Phosph. = 60 ml/min (according to MDRD formula) 7) Normal blood Thyroid-Stimulating Hormone (TSH) 8) Ability to understand and sign informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1) AIDS-defining illness (category C) diagnosed within the last 12 months prior to study entry 2) History of HIV related encephalopathy 3) Active opportunistic infection including active tuberculosis 4) Previous treatment with IL-2 or IL-7 at any time prior to study entry 5) 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 6) Poor compliance on HAART or any other chronic treatment that in the opinion of the investigator will interfere with protocol participation 7) 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 8) 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. 9) Any history of severe auto-immune disease requiring systemic treatment or hospitalization, or any active auto-immune disease requiring treatment (including multiple sclerosis) 10) History of splenectomy 11) Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary spherocytosis, Gaucher’s Disease, and autoimmune hemolytic anemia 12) Chronic hepatitis B or C 13) HIV-2, HTLV-1 or HTLV-2 seropositivity 14) Cirrhosis of any origin, and alcoholic or non alcoholic steato-hepatitis, either proven histologically or suspected 15) Hypertension with a resting systolic blood pressure > 140 or a resting diastolic blood pressure > 90 mm despite adequate antihypertensive treatment 16) Any cardiac, pulmonary, thyroid, renal, hepatic, gastrointestinal, neurological (central or peripheral) disease requiring therapy and considered as significant by the investigator or a severe disorder of hemostasis 17) Any serious illness requiring systemic treatment and/or hospitalization until the patient either completes therapy or is clinically stable on therapy, in the opinion of the principal investigator, for at least 30 days prior to study entry 18) Pregnant or lactating women. Women of childbearing potential must have a negative serum or urine pregnancy test at study entry 19) Refusal or inability to practice contraception regardless of the gender of the patient 20) Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. Patients must agree to refrain from substance abuse use during the course of the study. 21) Any past or current psychiatric illness that, in the opinion of the investigator, would interfere with adherence to study requirements or the ability and willingness to give written informed consent 22) Use of any other investigational antiretroviral agents 23) Participation in another investigational interventional study within the last 6 months prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the biological activity and safety of repeated cycles of CYT107 at 20 ?g/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.;Secondary Objective: 1) To further characterize the long term safety in a context of repeated cycles of CYT107 2) To characterize CYT107 Pharmacokinetics (PK) / Pharmacodynamics (PD) 3) To build a population PK/PD model of CYT107 activity 4) To characterize the key immuno-pharmacological effects such as a. Increase of T cells cycling b. Inhibition of T cells apoptosis c. Increase of thymopoiesis and recovery of T cells repertoire diversity d. Increase of T cells homing e. To assess the anti-HIV specific responses f. To assess the recall antigens response 5) To assess CYT107 effect on HIV-induced chronic systemic immune hyperactivation and its consequences 6) To measure the time spent under prophylactic treatment for opportunistic infections;Primary end point(s): Restoration and maintain of CD4+ T cells count above 500 cells/?L in HIV-infected patients with CD4+ T cells count remaining between 101-350 cells/?L after at least 2 years of HAART and plasma HIV RNA < 50 copies/mL for at least 18 months. Safety assessments will include a close monitoring of the CYT107 impact on • HIV RNA viral load, • measure of the pro-viral DNA in CD4+ T cells, • anti-CYT107 immunogenicity, • Incidence of all adverse events. | — |
Countries
Italy
Outcome results
None listed