Open Labelled, Randomized Study to Evaluate the Efficacy, Safety and Dose Selection of VM-1500A-LAI Drug in HIV-infected Patients Transferred From Previous Stable Therapy (NNRTI + 2NRTI), Including ELPIDA®

NCT05163535 | Completed Phase 1

• 1 other identifier: HIV-VM1500ALAI-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Open labelled, randomized study to evaluate the efficacy, safety and dose selection of VM-1500A-LAI drug in HIV-infected patients transferred from previous stable therapy (NNRTI + 2NRTI), including ELPIDA®.

Conditions

HIV-1-infection

Keywords

HIV-1; LAI

Outcome Measures

Primary Outcomes (1)

• Concentration of VM1500A in plasma and RBCs

  Assess the clinical and virological efficacy of three dosage regimens of VM-1500A-LAI in HIV-infected patients transferred to VM-1500A-LAI from previous stable therapy (NNRTI + 2NRTI), including ELPIDA®, 20 mg capsules, lasting at least 6 months

  16 weeks

Study Arms (4)

VM-1500A-LAI (1200 mg, 1200 mg, 1200 mg)

EXPERIMENTAL

VM-1500A-LAI 3 i / m injections with an interval of 4 weeks (1200 mg, 1200 mg, 1200 mg) during daily therapy with 2NRTIs for 12 weeks

Drug: VM-1500A-LAI

VM-1500A-LAI (1200 mg, 900 mg, 900 mg)

EXPERIMENTAL

VM-1500A-LAI 3 i / m injections with an interval of 4 weeks (1200 mg, 900 mg, 900 mg) during daily therapy with 2NRTIs for 12 weeks

Drug: VM-1500A-LAI

VM-1500A-LAI (1200 mg, 600 mg, 600 mg)

EXPERIMENTAL

VM-1500A-LAI 3 i / m injections with an interval of 4 weeks (1200 mg, 600 mg, 600 mg) during daily therapy with 2NRTIs for 12 weeks

Drug: VM-1500A-LAI

ELPIDA®

OTHER

ELPIDA®, 20 mg capsules and 2NRTIs, daily therapy for 12 weeks

Other: ELPIDA®

Interventions

VM-1500A-LAI DRUG

VM-1500A (parent drug of elsulfavirine) IM injection dosage form

Also known as: VM-1500A, VM-1500, ELPIDA®

VM-1500A-LAI (1200 mg, 1200 mg, 1200 mg); VM-1500A-LAI (1200 mg, 600 mg, 600 mg); VM-1500A-LAI (1200 mg, 900 mg, 900 mg)

ELPIDA® OTHER

Elsulfavirine capsules

Also known as: VM-1500

ELPIDA®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Patient Information Sheet and Informed Consent Form
• Men and women aged 18 and over;
• HIV-1 infection confirmed serologically by ELISA or immunoblot analysis (or documented HIV-1 infection);
• Clinically stable HIV infection (clinical stages 1 or 2 according to the WHO classification, Appendix 1)
• Stable doses of NNRTIs (ELPIDA®, 20 mg capsules) + 2NRTIs for 6 months before screening;
• HIV-1 RNA plasma level ≤ 50 copies/ml at screening;
• СD4+ Т-cells count ≥ 200 cells/mm3 at screening;
• Laboratory parameters;
• The patients' consent to use adequate contraception methods during the study (condom with spermicide).

You may not qualify if:

• 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.
• 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
• 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;
• History of tuberculosis of any localization or on screening according to chest x-ray (in frontal and lateral projections);
• 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);
• 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;
• Course intake of immunomodulators (interferons, interleukins), immune-suppresive therapy (cyclosporins), glucocorticoids 1 month before screening
• 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
• 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;
• Taking excluded drugs from the list of "excluded drugs";
• Taking other study drugs for 12 weeks or 5 drug half-lives (whichever is longer) prior to screening;
• 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;
• Systemic autoimmune disorders and connective tissue diseases, which require prior or current treatment with systemic glucocorticoid drugs, cytostatics or penicillamine;
• 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;
• 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.

Sponsors & Collaborators

• Viriom: lead

Study Sites (2)

Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor

Moscow, 111123, Russia

Location

St. Petersburg State Medical Institution " Center for AIDS and Infectious Diseases"

Saint Petersburg, 190103, Russia

Location

MeSH Terms

Interventions

elsulfavirine

Study Officials

• Anastasia Pokrovskaya, PhD

  Central Research Institute of Epidemiology of Rospotrebnadzor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 20, 2021
• Study Start: January 19, 2021
• Primary Completion: August 3, 2021
• Study Completion: August 3, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)