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

UNKNOWNPHASE2/PHASE3

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

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

NCT05204394•Viriom

View on ClinicalTrials.gov

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.

Detailed Description

Eligible patients will be randomized (1:1:1) into 3 treatment groups - LAI 600 (ELPIDA+VM-1500A-LAI 600 mg), LAI 900 (ELPIDA+VM-1500A-LAI 900 mg), and Standard of Care (SoC) therapy. Patients of LAI groups will be assigned by ELPIDA®, 20 mg capsules (and same 2NRTIs) daily therapy for 4 weeks, then one IM injection of 1200 mg VM-1500A-LAI followed by 5 IM monthly injections of 600 mg or 900 mg VM-1500A-LAI QM. When all patients in the VM-1500A-LAI 600mg and VM-1500A-LAI 900 mg dose cohorts complete 24 weeks, the interim analysis will be performed in order to select the dosage regimen for VM-1500A-LAI to continue for additional 28 weeks for a total of 52 weeks of treatment. The analysis will be based on efficacy assessment (number of patients treated with VM1500-LAI who showed the viral load ≥ 50 copies/ml at Week 24 using FDA snapshot algorithm as well as on the basis of a safety and tolerability assessment (assessment of the frequency and severity of AEs associated with the study drug). The optimal dosage regimen will be selected by the IDMC. 4 weeks after the End of Treatment visit, subjects will come for the Follow-up visit.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
•* СD4+ Т-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
+16 more criteria

Locations (2)

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

Moscow, Russia

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

Saint Petersburg, Russia

Key Dates

Start Date

April 1, 2022

Primary Completion Date

September 30, 2023

Completion Date

October 16, 2023

Last Updated

January 24, 2022

Enrollment

438

ESTIMATED participants

Conditions

HIV-1-infection

Interventions

VM-1500A-LAI

DRUG

Standard of Care

OTHER

Contacts

Elena Yakubova, PhD

CONTACT

+79162063097 ey@chemrar.ru

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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