Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT05163535
Eligibility Criteria:
Inclusion Criteria:
1. Signed Patient Information Sheet and Informed Consent Form
2. Men and women aged 18 and over;
3. HIV-1 infection confirmed serologically by ELISA or immunoblot analysis (or documented HIV-1 infection);
4. Clinically stable HIV infection (clinical stages 1 or 2 according to the WHO classification, Appendix 1)
5. Stable doses of NNRTIs (ELPIDA®, 20 mg capsules) + 2NRTIs for 6 months before screening;
6. HIV-1 RNA plasma level ≤ 50 copies/ml at screening;
7. СD4+ Т-cells count ≥ 200 cells/mm3 at screening;
8. Laboratory parameters;
9. The patients' consent to use adequate contraception methods during the study (condom with spermicide).
Exclusion Criteria:
1. Presence of known primary HIV-1 resistance to ART. Viral resistance mutations are defined as any basic mutations of resistance to NNRTI pursuant to the renewed list of the International Community of HIV-1 Resistant AIDS Mutations (2013) associated with drug resistance for any genotype.
2. 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;
3. 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
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;
5. History of tuberculosis of any localization or on screening according to chest x-ray (in frontal and lateral projections);
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 before Screening. Patients who participated in study HIV-VM1500-06 may be included in this study;
8. Course intake of immunomodulators (interferons, interleukins), immune-suppresive therapy (cyclosporins), glucocorticoids 1 month before screening
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; hypersensitivity to any of the components, including lactose intolerance, or the presence of contraindications to the appointment of ELPIDA® or ART drugs;
11. Taking excluded drugs from the list of "excluded drugs";
12. Taking other study drugs for 12 weeks or 5 drug half-lives (whichever is longer) prior to screening;
13. Signs of expressed uncontrolled associated disease, e.g., disorders of nervous, respiratory, cardiac-vessel (including unstable angina, myocardial infarction, transient ischemic attack or stroke 12 months before screening) systems, kidneys, liver, endocrinic system and gastrointestinal tract, which as the Investigator may think could prevent the patient from participation in the study;
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; women at the child-birthing age (including non-sterilized by surgical means during post-menopause period less than 2 years), who do not use adequate contraception methods;
16. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05163535
Study Brief:
Protocol Section:
NCT05163535