The patients in the experimental group will conduct a total of 32 visits to the center for the clinical trial, and each therapeutic course will include 16 patient visits, with a break of 12 days between the two courses. The patients in the control group will conduct three visits to the center for the clinical trial. During the Visit Day 1 (screening), Visit Day 63 (end of the 12-day break) and Visit Day 126 (after the second course of treatment) the patients in both groups (experimental and control) will be tested in order to evaluate the efficacy and safety of the administered treatment. During the other visits – from Visit Day 2 to Visit Day 51 during the first course of the treatment and from Day Visit 64 to Visit Day 114 during the second course of treatment, the patients in the experimental group will visit the research center for the administration of the investigational medication.
The clinical trial will make comparative assessment of the efficacy and safety related to the administration of ITV-1 in patients with diagnosed HIV infection while applying antiretroviral therapy. For that purpose, HIV-positive patients in an advanced stage of AIDS, who have voluntarily signed an informed consent to participate in the clinical trial, will be divided randomly into two groups – experimental and control. The participants in the experimental group will receive the investigational product – ITV-1 in the form of intramuscular injections within 2 successive treatment courses with a 10-day break between them while receiving antiretroviral therapy. The participants in the control group will be monitored while receiving antiretroviral therapy. Within the 2 groups the participants will be further stratified according to the number of CD4 + T- lymphocytes. The investigational medication (ITV-1) will be administered to the patients by intramuscular injections in two consecutive days during each week. The total treatment period will be 16 weeks with a 10-day break between the two treatment courses.
The clinical testing schedule includes a screening visit, during which all the patients, who pass the screening and have no contraindications for participation in the trial, will be administered the first dosage of the investigational medication. After that, 15 more visits will be conducted (from Day 2 to Day 51), during which the patients will visit the research center within 2 consecutive days each week in order to receive injections with the investigational medication and will be monitored for adverse events. After the visit, on Day 51, a 12-day break will take place, at the end of which Visit Day 63 will be held in order to assess the condition of the patients and to take blood samples to determine the indicators of efficacy and safety. Later, the patient will receive the second cycle with injections with the investigational medication by means of 16 visits to the research center (from Day 64 to Day 114) and on Day 126 the final visit will be held. The total duration of the participation of the patients in the clinical trial will not exceed 18 weeks and this period includes as well the 12-day break between the two courses of ITV-1. Upon completion of their participation in the trial, the patients will continue their treatment with antiretroviral medications and visits to the research center for disease control.
The present clinical trial will be conducted in accordance with the Declaration of Helsinki (1964 and the subsequent supplements), the current rules of the Good Clinical Practice and the applicable European and local laws. After the completion of the trial, the patients will be given the right to continue their treatment in accordance with the good clinical practice and at the discretion of their physician.