Study to Evaluate Efficacy and Safety of Switching to VM-1500A-LAI + 2NRTIs From the 1st Line Standard of Care Therapy

NCT05204394 | Unknown Phase 2

• 1 other identifier: HIV-VM1500ALAI-03
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 2

Brief Summary

Multicenter, open-label, randomized, active control study to evaluate efficacy and safety of switching to VM-1500A-LAI + 2NRTIs from the 1st line standard of care therapy for 48 weeks. The 1st part of the study will select one of 2 dose cohorts: 600mg or 900mg.

Conditions

HIV-1-infection

Keywords

HIV-1; LAI

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with plasma HIV-1 RNA level > 50 copies/mL

  Proportion of participants with plasma HIV-1 RNA level \> 50 copies/mL at Week 48 using the snapshot algorithm (FDA).

  48 Weeks

Secondary Outcomes (6)

• Percentage of patients with undetectable viral load

  48 Weeks

• Proportion of patients with Confirmed Virologic Failure

  48 Weeks

• Change in the absolute lymphocyte counts

  48 Weeks

• Percentage of patients with developed HIV-1 resistance

  48 Weeks

• Incidence of AEs / SAEs

  48 Weeks

Study Arms (3)

VM-1500A-LAI 600mg

EXPERIMENTAL

20mg Elpida® 2 weeks run-in period followed by VM-1500A-LAI 600mg i / m Q4W injections with the background of oral 2NRTIs QD.

Drug: VM-1500A-LAI

VM-1500A-LAI 900mg

EXPERIMENTAL

20mg Elpida® 2 weeks run-in period followed by VM-1500A-LAI 900mg i / m Q4W injections with the background of oral 2NRTIs QD.

Drug: VM-1500A-LAI

Standard or Care

OTHER

Any approved 1st line oral HIV treatment regimen

Other: Standard of Care

Interventions

VM-1500A-LAI DRUG

Injectable nanoformulation of depulfavirine (parent drug of elsulfavirine)

Also known as: VM-1500A, Depulfavirine

VM-1500A-LAI 600mg; VM-1500A-LAI 900mg

Standard of Care OTHER

Any oral 1st line approved HIV treatment regimen

Also known as: SoC

Standard or Care

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 or older at the time of signing the informed consent;
• HIV-1 infection confirmed serologically by ELISA or immunoblot analysis (or documented HIV-1 infection);
• Stable doses of standard-of-care antiretroviral therapy (NNRTI + 2NRTI) for at least 6 months prior screening;
• 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;
• СD4+ Т-cells count ≥ 200 cells/mm3 at screening;
• Adequate organ function as documented by laboratory test results;
• 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.
• 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.

You may not qualify if:

• 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
• 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).
• 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)
• History of tuberculosis of any localization or ongoing at screening according to chest x-ray (in frontal and lateral projections) and other serology testing;
• 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 or 5 half-lives before Screening, whichever is longer.;
• 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.
• 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 such as hypersensitivity to lactose intolerance, or the presence of contraindications to the appointment of ELPIDA® or ART drugs;
• Treatment with prohibited drugs from the list of "prohibited drugs" (Appendix 3);
• 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;
• Clinically significant cardiovascular diseases including:
• Myocardial infarction within 12 months before screening
• Unstable angina within 12 months before screening

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

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anastasia Pokrovskaya, PhD

  Central Research Institute of Epidemiology of Rospotrebnadzor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Yakubova, PhD

CONTACT

+79162063097; ey@chemrar.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: April 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: October 16, 2023
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)