Randomized Study on Multiple Cycles of Interleukin-7 in HIV Patients Immune Non-responders (NCT01241643) | Clinical Trial Compass
TerminatedPhase 2
Randomized Study on Multiple Cycles of Interleukin-7 in HIV Patients Immune Non-responders
Stopped: Terminated \[CYTHERISSA filed for banckcuptcy in June 2013.Subjects treated by CYT107 were followed up for at the least 3 months.\]
Italy, South Africa, Switzerland92 participantsStarted 2010-09
Plain-language summary
This is a Phase II multicenter, open-labeled, controlled, randomized study assessing weekly doses of Interleukin-7 (CYT107)
Who can participate
Age range18 Years
SexALL
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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
✓. Age ≥18
✓. 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:
✓. Normal blood Thyroid-Stimulating Hormone (TSH)
✓. Ability to understand and sign informed consent
Exclusion criteria
✕. AIDS-defining illness (category C) diagnosed within the last 12 months prior to study entry
What they're measuring
1
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.
✕. 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.