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HIV-1-infectionPhase 1/2NCT05163535

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®

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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®. 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 and ELPIDA®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesRussia
Study dates
19 Jan 2021to 3 Aug 2021
Phase
Phase 1/2
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 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;
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  • 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).

Who cannot join

  • 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.
  • 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
  • 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);
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  • 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.

Trial locations and contacts

2 sites in 1 country.

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

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®.

Read the detailed description

The clinical study will consist of the following stages:

  1. Screening: On Week 2, after signing the Patient Information Sheet and the Informed Consent form, subjects will undergo screening procedures to assess the inclusion/exclusion criteria. Patients meeting all inclusion / exclusion criteria will be invited to the center for randomization and initiation of study drug therapy.
  2. Study treatment period: Once the inclusion / exclusion criteria have been confirmed, patients will be randomized to one of four treatment groups. For patients assigned to Groups 1, 2 and 3, all i/m injections of VM-1500A-LAI will be administered at Week 0, Week 4 and Week 8 by the study physician at the center, where they will remain monitored for up to 2 hours. Patients will also receive 2NRTI according to the standard regimen. Blood samples for PK study will be taken immediately before and 2 hours after each i/m injection of VM-1500A-LAI. Patients assigned to Group 4 will receive daily ELPIDA® 20 mg in the morning and 2NRTIs according to the standard regimen.
  3. End of Therapy: At the end of the study therapy course, patients will be invited to the study center for a Week 12 visit for the end of therapy visit procedures.
  4. Follow-up Observation period:

After the end of the course of study therapy, patients will be monitored for another 4 weeks. Patients will be invited to the center for a Follow-up Visit at Week 16. Follow-Up to obtain the data on adverse events will be continued for up to 30 days after the last visit or the last study procedure planned in the Study Protocol.

Conditions
HIV-1-infection
Being tested
VM-1500A-LAI, ELPIDA®
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, VM-1500, ELPIDA®

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

  • ELPIDA®Other

    Also called VM-1500

    Elsulfavirine capsules

Study groups in NCT05163535
Study groupRoleWhat they receive
VM-1500A-LAI (1200 mg, 1200 mg, 1200 mg)ExperimentalVM-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
Receives: Drug: VM-1500A-LAI
VM-1500A-LAI (1200 mg, 900 mg, 900 mg)ExperimentalVM-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
Receives: Drug: VM-1500A-LAI
VM-1500A-LAI (1200 mg, 600 mg, 600 mg)ExperimentalVM-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
Receives: Drug: VM-1500A-LAI
ELPIDA®OtherELPIDA®, 20 mg capsules and 2NRTIs, daily therapy for 12 weeks
Receives: Other: ELPIDA®

What is being measured

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

  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

    Measured: 16 weeks

Timeline

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

  1. First posted20 Dec 2021
  2. Study start19 Jan 2021
  3. Primary completion3 Aug 2021
  4. Study completion3 Aug 2021

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05163535
Sponsor's protocol ID
HIV-VM1500ALAI-02
Status last verified
Dec 2021
First submitted
6 Dec 2021
Last updated
11 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 1/2 study testing VM-1500A-LAI and ELPIDA® 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 9 inclusion and 16 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: finished, as of the sponsor's last update on 11 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of VM1500A in plasma and RBCs (time frame: 16 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 NCT05163535.

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 11 Jan 2022.

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