HIV InfectionsPhase 1NCT05204121
Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers
A Phase 1 study testing Elpida in people with HIV Infections, run by Viriom at 1 site in Russia.
Trial summary
A randomized once weekly dose for 8 weeks, study in Healthy HIV-Uninfected Volunteers. Each of 3 parallel groups (40 mg, 80 mg and 160mg) enrolls 12 subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Elpida
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteRussia
- Study dates
- 18 Dec 2018to 2 Apr 2019
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 to 55 years;
- Verified diagnosis "healthy" according to medical history, physical examination, assessment of vital signs, electrocardiography (ECG), investigations performed in the last 14 days prior to the first administration of IP;
- Body mass index (BMI) from 18.5 kg/m2 to 30 kg/m2 (inclusive), bodyweight of 50 kg or higher;
- Negative result of alcohol and drug tests;
- Women must be in postmenopause for at least 2 years, be surgically sterile or use two reliable methods of contraception from the day of screening and until 3 months after the last dose;
- Men must use two reliable methods of contraception* from the day of screening and until 3 months after the last dose;
- Ability to understand the meaning of the study and any risks associated with participation. Ability to interact with the investigator, participate and comply with the requirements of the study throughout its duration;
- Willingness to sign written consent to participate in the study after reading Informed Consent Form with the opportunity to discuss any questions with the investigator (and/or his/her representative).
Who cannot join
- Participation in more than one group of investigational therapy;
- Past or present diseases of the cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood that may interfere with achievement of objectives of this study or affect the safety of a volunteer;
- The values of laboratory and instrumental parameters, beyond the limit of normal ;
- Past or present diseases or pathologies, including surgical interventions in the gastrointestinal tract that, in the opinion of the Investigator, may affect the absorption, distribution, metabolism or excretion of the investigational product;
- A systolic pressure of less than 90 mm Hg or greater than 130 mm Hg; diastolic pressure of less than 60 mm Hg or greater than 85 mm Hg; pulse rate of less than 60 bpm or greater than 90 bpm (at screening);
- Deviations detected during 12-lead ECG, or QT/QTc interval > 450 milliseconds (ms) for men and > 470 ms for women;
Show all 18Show fewer
- Administration of any drugs n, including over-the-counter products, herbal, food, dietary or vitamin supplements 14 days before the first administration of the investigational product;
- Administration of the following drugs for 28 days prior to screening: corticosteroids (any route of administration); IP that inhibit the activity of cytochrome P450 3A4 (CYP3A4; for example, ritonavir and other drugs for human immunodeficiency virus (HIV), ketoconazole, itraconazole, or similar azole antifungals and macrolide antibiotics such as erythromycin), or the use of any drugs with a significant likely effect on functions of organs (for example, barbiturates, omeprazole, cimetidine);
- Hepatitis B (HBsAg), antibodies to hepatitis C and HIV, a positive test for syphilis;
- Positive pregnancy test (for women);
- Acute infectious diseases less than 4 weeks before screening;
- Unstable sleeping hours (for example, night shift, sleep disorders, insomnia, jet lag, etc.);
- Signs of alcohol or drug addiction; intake of alcohol or drugs 4 days prior to screening and during the study; smoking cigarettes 3 months prior to screening and during the study; positive drug and/or alcohol test;
- Complicated allergic history (including intolerance to medication, including hypersensitivity to the active substance/excipients of the investigational drug) and food allergy;
- Blood/plasma donation (450 mL of blood or plasma or more) less than 2 months before screening;
- Participation in another clinical study or administration of any investigational products less than 3 months before screening;
- Any other concomitant medical or significant mental conditions that render a volunteer unsuitable for participation in the clinical study;
- A volunteer who is considered for enrollment in the study is an employee of the study site or company of the Sponsor or a member of an employee's family
Trial locations and contacts
1 site in 1 country.
Russia1 site
Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
Moscow, 119991
About this study
Official title: Phase Ib, Single-Center, Randomized Study of Safety, Tolerability and Pharmacokinetics of Elpida in Healthy HIV-Uninfected Volunteers
A randomized once weekly dose for 8 weeks, study in Healthy HIV-Uninfected Volunteers. Each of 3 parallel groups (40 mg, 80 mg and 160mg) enrolls 12 subjects.
Read the detailed description
The study aims to assess safety, tolerability and PK of once weekly administration of Elpida in different doses.
- Conditions
- HIV Infections
- Being tested
- Elpida
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElpidaDrug
Also called elsulfavirine, VM-1500, VM1500
elsulfavirine, capsules
| Study group | Role | What they receive |
|---|---|---|
| Elpida 40 mg once weekly | Experimental | elsulfavirine 40mg orally once weekly for 8 weeks Receives: Drug: Elpida |
| Elpida 80 mg once weekly | Experimental | elsulfavirine 80mg orally once weekly for 8 weeks Receives: Drug: Elpida |
| Elpida 160 mg once weekly | Experimental | elsulfavirine 160mg orally once weekly for 8 weeks Receives: Drug: Elpida |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs and SAEs
Incidence of AEs and SAEs
Measured: 77 days
Secondary outcomes (2)
elsulfavirine plasma concentration
elsulfavirine plasma concentration
Measured: 77 days
VM1500A plasma concentration
active metabolite plasma concentration
Measured: 77 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start18 Dec 2018
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viriom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena Smolyarchuk, MD, PhD, Principal investigator, Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204121
- Sponsor's protocol ID
- HIV-VM1500-09
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib, Single-Center, Randomized Study of Safety, Tolerability and Pharmacokinetics of Elpida in Healthy HIV-Uninfected Volunteers
- ClinicalTrials.gov ID
- NCT05204121
- Acronym / sponsor ID
- HIV-VM1500-09
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ViriomIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized once weekly dose for 8 weeks, study in Healthy HIV-Uninfected Volunteers. Each of 3 parallel groups (40 mg, 80 mg and 160mg) enrolls 12 subjects.
Detailed description
The study aims to assess safety, tolerability and PK of once weekly administration of Elpida in different doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elpida 40 mg once weekly | Experimental | Drug: Elpidaelsulfavirine 40mg orally once weekly for 8 weeks |
| Elpida 80 mg once weekly | Experimental | Drug: Elpidaelsulfavirine 80mg orally once weekly for 8 weeks |
| Elpida 160 mg once weekly | Experimental | Drug: Elpidaelsulfavirine 160mg orally once weekly for 8 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women aged 18 to 55 years;
- Verified diagnosis "healthy" according to medical history, physical examination, assessment of vital signs, electrocardiography (ECG), investigations performed in the last 14 days prior to the first administration of IP;
- Body mass index (BMI) from 18.5 kg/m2 to 30 kg/m2 (inclusive), bodyweight of 50 kg or higher;
- Negative result of alcohol and drug tests;
- Women must be in postmenopause for at least 2 years, be surgically sterile or use two reliable methods of contraception from the day of screening and until 3 months after the last dose;
Key exclusion criteria (18 listed)
- Participation in more than one group of investigational therapy;
- Past or present diseases of the cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood that may interfere with achievement of objectives of this study or affect the safety of a volunteer;
- The values of laboratory and instrumental parameters, beyond the limit of normal ;
- Past or present diseases or pathologies, including surgical interventions in the gastrointestinal tract that, in the opinion of the Investigator, may affect the absorption, distribution, metabolism or excretion of the investigational product;
- A systolic pressure of less than 90 mm Hg or greater than 130 mm Hg; diastolic pressure of less than 60 mm Hg or greater than 85 mm Hg; pulse rate of less than 60 bpm or greater than 90 bpm (at screening);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElpidaAlso: elsulfavirine, VM-1500, VM1500elsulfavirine, capsules | Drug | Elpida 160 mg once weekly, Elpida 40 mg once weekly, Elpida 80 mg once weekly |
Primary outcome
Incidence of AEs and SAEs
Time frame: 77 days
Incidence of AEs and SAEs
2 secondary outcomes
elsulfavirine plasma concentration
Time frame: 77 days
VM1500A plasma concentration
Time frame: 77 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Smolyarchuk, MD, PhD principal investigator
Sechenov First Moscow State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elpida in people with HIV Infections, run by Viriom at 1 site 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 8 inclusion and 18 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 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 1 site 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 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.
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?
Incidence of AEs and SAEs (time frame: 77 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.