Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Cytheris SA
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
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
