| Eligibility |
Inclusion Criteria:
1. Signed Patient Information Sheet and Informed Consent Form
2. Men and women aged 18 or older at the time of signing the informed consent;
3. HIV-1 infection confirmed serologically by ELISA or immunoblot analysis (or documented
HIV-1 infection);
4. Stable doses of standard-of-care antiretroviral therapy (NNRTI + 2NRTI) for at least 6
months prior screening;
5. Serological confirmation of adequate virological suppression within 6 and 12 months
before screening as documented by :
- HIV-1 RNA plasma level < 50 copies/ml at screening;
- ?D4+ ?-cells count = 200 cells/mm3 at screening;
6. Adequate organ function as documented by laboratory test results;
7. Female patients must be postmenopausal not less than 2 years, surgically sterile, or
if of child-bearing potential, must use two reliable forms of contraception from
screening to 3 months after the end of dosing; two reliable forms of contraception
include use of condom with spermicide by male partner, or diaphragm with spermicide,
or condom use by male partner and diaphragm, or condom use by male partner and
non-hormonal intrauterine device.
8. Male patients must use two reliable forms of contraception from screening to 3 months
after the end of dosing; two reliable forms of contraception include condom with
spermicide, or diaphragm use by female partner with spermicide, or condom and
diaphragm use by female partner, or condom and intrauterine device use by female
partner.
Exclusion Criteria:
1. Acute hepatitis or cirrhosis of the liver of any etiology; HBsAg or antibodies to
hepatitis C (in the case of Anti-HCV +, the exclusion criterion must be confirmed by
determining a positive HCV RNA test) at screening;
2. Signs of acute infection or presence of syphilis, hepatitis A, Toxoplasma gondii,
cytomegalovirus, gonorrhea and Chlamydia trachomatis tests results within 30 days
prior to screening
3. Patients with known or suspected active Coronavirus Disease 2019 (COVID-19) infection
OR contact with an individual with known COVID-19, within 14 days of study enrollment
(World Health Organization [WHO] definitions).
4. Opportunistic infections referred to Category C of the classification of the Center
for disease control (CDC), dated 2008, except for Kaposi's sarcoma not requiring
system therapy (Appendix 2)
5. History of tuberculosis of any localization or ongoing at screening according to chest
x-ray (in frontal and lateral projections) and other serology testing;
6. History of malignant neoplasms (except for basal cell epithelioma or squamous cell
carcinoma of skin and in situ cervical carcinoma, which were resected and healed more
than 5 years ago);
7. Participation in other clinical studies or therapy with other study drugs within 3
months or 5 half-lives before Screening, whichever is longer.;
8. Treatment with immunomodulators (interferons, interleukins), immune-suppressive
therapy (cyclosporins), glucocorticoids 1 month before screening
a. Washout from these medications for the purpose of participation in tis clinical
trials needs to be done safely and only if medically acceptable.
9. Current alcoholic or drug addiction, which the researcher may think to hinder the
patient to take part in the study and adhere to all requirements per protocol
10. Hypersensitivity to any component of the study drug such as hypersensitivity to
lactose intolerance, or the presence of contraindications to the appointment of
ELPIDA® or ART drugs;
11. Treatment with prohibited drugs from the list of "prohibited drugs" (Appendix 3);
12. Signs of manifest uncontrolled and/or unstable concomitant disease, e.g., disorders of
nervous, respiratory, systems, kidneys, liver, endocrine system and gastrointestinal
tract, which as the Investigator may think could prevent the patient from
participation in the study;
13. Clinically significant cardiovascular diseases including:
- Myocardial infarction within 12 months before screening
- Unstable angina within 12 months before screening
- Congestive heart failure Class III or IV according to the New York Heart
Association criteria (NYHA)
- Clinically significant ventricular arrhythmia including ventricular tachycardia,
ventricular fibrillation, history of cardiac arrest, atrioventricular block
(Mobitz II or III), use of cardiostimulator
- QTc interval > 450 ms in men or 470 ms in women (ECG) (calculated according to
Fredericia formula), or a diagnosis of long QT syndrome
- Hypotension (systolic blood pressure < 86 mm Hg or bradycardia with a heart rate
of < 50 beats per minute (ECG) except when caused by medications (e.g.
beta-blockers).
- Uncontrolled/unstabe arterial hypertension (systolic arterial pressure > 170
millimeters of mercury or diastolic blood pressure > 105 millimeters of
mercury)
14. Systemic autoimmune disorders and connective tissue diseases, which require prior or
current treatment with systemic glucocorticoid drugs, cytostatics or penicillamine;
15. Pregnant or lactating women or women planning to get pregnant during the clinical
study;
16. The patient has a tattoo or other dermatological condition overlying the gluteus
region which may interfere with interpretation of injection site reactions.
17. History of hypersensitivity (analphylaxis) reactions upon intramuscular injection
18. Positive breath alcohol test or/and positive urine drug screen
19. Inability to read or write; unwillingness to understand and adhere to the study
protocol procedures; non-compliance with the drugs intake regimen or execution of
procedures, which as the Investigator believes may affect the study results or
subject's safety and prevent the subject from further participation in the study; any
other concomitant medical or serious psychological conditions making the subject not
eligible to participate in the clinical study restrict the legality of obtaining the
Informed Consent or may affect the patient's ability to participate in the study.
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