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HIV-1-infectionPhase 2/3NCT05204394

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

A Phase 2/3 study testing VM-1500A-LAI in people with HIV-1-infection, run by Viriom at 2 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1-infection
What is being tested?
VM-1500A-LAI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
438 participants
Where
2 sitesRussia
Study dates
1 Apr 2022to 16 Oct 2023
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
  • 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);
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  • 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
  • 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
  • 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)
  • 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;
  • The patient has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.
  • History of hypersensitivity (analphylaxis) reactions upon intramuscular injection
  • Positive breath alcohol test or/and positive urine drug screen
  • 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.

Trial locations and contacts

2 sites in 1 country.

Elena Yakubova, PhD contact

+79162063097

ey@chemrar.ru

Russia2 sites

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

    Moscow, 111123

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

    Saint Petersburg, 190103

Other trials in Russia

About this study

Official title: 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

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.

Read the 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.

Conditions
HIV-1-infection
Being tested
VM-1500A-LAI, Standard of Care
Keywords
HIV-1, LAI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VM-1500A-LAIDrug

    Also called VM-1500A, Depulfavirine

    Injectable nanoformulation of depulfavirine (parent drug of elsulfavirine)

  • Standard of CareOther

    Also called SoC

    Any oral 1st line approved HIV treatment regimen

Study groups in NCT05204394
Study groupRoleWhat they receive
VM-1500A-LAI 600mgExperimental20mg Elpida® 2 weeks run-in period followed by VM-1500A-LAI 600mg i / m Q4W injections with the background of oral 2NRTIs QD.
Receives: Drug: VM-1500A-LAI
VM-1500A-LAI 900mgExperimental20mg Elpida® 2 weeks run-in period followed by VM-1500A-LAI 900mg i / m Q4W injections with the background of oral 2NRTIs QD.
Receives: Drug: VM-1500A-LAI
Standard or CareOtherAny approved 1st line oral HIV treatment regimen
Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 48 Weeks

Secondary outcomes (6)

  1. Percentage of patients with undetectable viral load

    Percentage of patients with HIV-1 RNA < 50 copies/ml at Week 48

    Measured: 48 Weeks

  2. Proportion of patients with Confirmed Virologic Failure

    Proportion of patients with Confirmed Virologic Failure (two consecutive plasma HIV-1 RNA levels > 200cmL after prior suppression to < 200copies/ml) at Week 48

    Measured: 48 Weeks

  3. Change in the absolute lymphocyte counts

    Change in the absolute CD4+ and CD8+ lymphocyte counts over 48 weeks

    Measured: 48 Weeks

  4. Percentage of patients with developed HIV-1 resistance

    Percentage of patients who develop HIV-1 resistance to study therapy over 48 weeks

    Measured: 48 Weeks

  5. Incidence of AEs / SAEs

    Measured: 48 Weeks

  6. VM-1500A plasma concentration

    To assess PK parameters of VM-1500A-LAI

    Measured: 48 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start1 Apr 2022 (estimated)
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion16 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
438 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05204394
Sponsor's protocol ID
HIV-VM1500ALAI-03
Status last verified
Jan 2022
First submitted
10 Jan 2022
Last updated
24 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing VM-1500A-LAI in people with HIV-1-infection, run by Viriom at 2 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elena Yakubova, PhD (+79162063097, ey@chemrar.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with plasma HIV-1 RNA level > 50 copies/mL (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05204394.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.

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