HIV-1-infectionPhase 1NCT03706924
Comparative Study of PK and BE of VM-1500FDC (Fixed-dose Combination) and Elpida® With Truvada® сo-administrated 1 Daily Fasting in Healthy Subjects
A Phase 1 study testing VM-1500FDC, Elpida® and Truvada® in people with HIV-1-infection, run by Viriom at 2 sites in Russia.
Trial summary
Open-label, randomized, parallel-group, comparative study of pharmacokinetics and bioequivalence of VM-1500FDC (elsulfavirine/emtricitabine/tenofovir fixed-dose combination) and Elpida® with Truvada® (emtricitabine/tenofovir) co-administered by healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- VM-1500FDC, Elpida® and Truvada®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Jun 2018to 12 Oct 2018
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking male subjects between the ages of 20 and 40 years (inclusive);
- Verified diagnosis of "healthy" according to standard clinical, laboratory and instrumental examination methods;
- Body weight from 60 to 95 kg and Body Mass Index from 19.0 to 27.0 kg/m;
- A negative result in tests for alcohol and drugs;
- The subject's consent to use adequate contraception methods during the study and 3 month after end of study: condom with spermicide (foam, gel, cream, suppositories);
- Signed the Participant Explanation Sheet and the Informed Consent Form.
Who cannot join
- Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood;
- Variables of standard laboratory and instrumental parameters are beyond the normal limits Variables of standard laboratory and instrumental parameters are beyond the normal limits (taking into account the acceptable limits of laboratory parameters);
- Surgical interventions on the gastrointestinal tract in medical history (except appendectomy);
- Systolic pressure less than 90 mm Mercury or above 130 mm Mercury, diastolic pressure less than 60 mm Mercury or above 85 mm Mercury, heart rate less than 60 BPM or more than 90 BPM at screening;
- Regular intake of drugs less than 2 weeks prior to screening (including herbal preparations and dietary supplements); intake of drugs that have a pronounced effect on hemodynamics, liver function, etc. (for example, barbiturates, omeprazole, cimetidine, etc.) less than 30 days prior to screening;
- Presence of antibodies to HIV and hepatitis C virus, presence of hepatitis В surface antigen, a positive syphilis test;
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- An unstable sleep structure (e.g., night work, sleep disorders, insomnia, recent return from another time zone, etc.), extreme physical activity (e.g. weight lifting), a special diet (e.g. vegetarian, vegan);
- Signs of alcohol (taking more than 10 units of alcohol per week ) or drug addiction; alcohol or drugs consumption within 4 days prior to screening; cigarettes smoking 3 months prior to screening; positive drug and/or alcohol test;
- Burdened allergic medical history (including drug intolerance and food allergy);
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- Hypersensitivity to tenofovir, elsulfavirine or emtricitabine, as well as any other component of the study drugs;
- Blood/plasma donation (450 ml of blood or plasma and more) less than 2 months prior to screening;
- Treatment with a study drug in framework of other clinical trials within 30 days prior to screening (including follow-up visits);
- Acute infectious diseases less than 4 weeks prior to screening;
- Incapable of reading or writing; no desire to understand and adhere to the study protocol procedures; non-compliance with the drugs intake regimen or execution of procedures, which as the Investigator may think may affect the study results or subject's safety and prevent the subject from further participation in the study; any other associated medical or serious psychological conditions making the subject not eligible to participate in the clinical study, restricting legality of obtaining the informed consent or affecting the subject's ability to take part in the study.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Private non - governmental health care institution "Scientific Clinical Center of the open joint - stock company Russian Railways"
Moscow, 125315
Central City Clinical Hospital Reutov
Reutov, Moscow Oblast, 143965
About this study
Official title: Open-Label, Randomized, Parallel-group, Comparative Study of Pharmacokinetics and Bioequivalence of VM-1500FDC (Viriom Ltd, Russia) and Elpida® (Viriom Ltd, Russia) and Truvada® (Gilead Sciences Ireland UC, UK) When сo-administrated Once Daily Fasting in Healthy Subjects
Open-label, randomized, parallel-group, comparative study of pharmacokinetics and bioequivalence of VM-1500FDC (elsulfavirine/emtricitabine/tenofovir fixed-dose combination) and Elpida® with Truvada® (emtricitabine/tenofovir) co-administered by healthy male subjects. The study will also assess safety profile of study drugs.
Read the detailed description
The study assesses PK and bioequivalence of the developed new drug VM-1500FDC - a fixed combination of three active substances: elsulfavirine (NNRTI), emtricitabine (NRTI) and tenofovir (NRTI) to Elpida® and Truvada® co-administered. The combination is intended for once daily administration (1 tablet) for the treatment of HIV-1 infection in adult patients. Thus, the purpose of this combination is to simplify the dosage regimen and improve patient compliance
- Conditions
- HIV-1-infection
- Being tested
- VM-1500FDC, Elpida®, Truvada®
- Keywords
- HIV -1, elsulfavirine fixed-dose combination
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VM-1500FDCDrug
Also called VM1500FDC
A fixed-dose combination of three active substances: tenofovir 300 mg + elsulfavirine 20 mg + emtricitabine 200 mg, film-coated tablets
Elpida®Drug
Also called VM-1500, VM1500, Elsulfavirine
Elpida®, capsules, elsulfavirine 20 mg
Truvada®Drug
Truvada® (tenofovir 300 mg / emtricitabine 200 mg), film-coated tablets
| Study group | Role | What they receive |
|---|---|---|
| VM-1500FDC | Experimental | VM-1500FDC (tenofovir 300 mg/elsulfavirine 20 mg/emtricitabine 200 mg), once daily fasting Receives: Drug: VM-1500FDC |
| Elpida® & Truvada® | Active comparator | Elpida®, 20 mg + Truvada® (tenofovir 300 mg / emtricitabine 200 mg), once daily fasting Receives: Drug: Elpida®; Drug: Truvada® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of VM1500A
Measured: 29 days
Plasma concentration of elsulfavirine
Measured: 29 days
Plasma concentration of emtricitabine
Measured: 29 days
Plasma concentration of tenofovir
Measured: 29 days
Secondary outcomes (1)
Frequency and severity of AEs and SAEs
Frequency and severity of AE, recorded after administration of the drug according to subjective complaints, changes in vital signs, ECG, laboratory results and physical examination compared to the baseline
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start1 Jun 2018
- Primary completion12 Oct 2018
- Study completion12 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viriom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena Mazygula, PhD, Principal investigator, Private non - governmental health care institution "Scientific Clinical Center of the open joint - stock company Russian Railways"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706924
- Sponsor's protocol ID
- HIV-VM1500FDC-01
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, Parallel-group, Comparative Study of Pharmacokinetics and Bioequivalence of VM-1500FDC (Viriom Ltd, Russia) and Elpida® (Viriom Ltd, Russia) and Truvada® (Gilead Sciences Ireland UC, UK) When сo-administrated Once Daily Fasting in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03706924
- Acronym / sponsor ID
- HIV-VM1500FDC-01
- Conditions
- HIV-1-infection
- Keywords
- HIV -1, elsulfavirine fixed-dose combination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- ViriomIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 12 Oct 2018 (actual)
- First posted
- 16 Oct 2018 (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.
Open-label, randomized, parallel-group, comparative study of pharmacokinetics and bioequivalence of VM-1500FDC (elsulfavirine/emtricitabine/tenofovir fixed-dose combination) and Elpida® with Truvada® (emtricitabine/tenofovir) co-administered by healthy male subjects. The study will also assess safety profile of study drugs.
Detailed description
The study assesses PK and bioequivalence of the developed new drug VM-1500FDC - a fixed combination of three active substances: elsulfavirine (NNRTI), emtricitabine (NRTI) and tenofovir (NRTI) to Elpida® and Truvada® co-administered. The combination is intended for once daily administration (1 tablet) for the treatment of HIV-1 infection in adult patients. Thus, the purpose of this combination is to simplify the dosage regimen and improve patient compliance
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VM-1500FDC | Experimental | Drug: VM-1500FDCVM-1500FDC (tenofovir 300 mg/elsulfavirine 20 mg/emtricitabine 200 mg), once daily fasting |
| Elpida® & Truvada® | Active comparator | Drug: Elpida®, Drug: Truvada®Elpida®, 20 mg + Truvada® (tenofovir 300 mg / emtricitabine 200 mg), once daily fasting |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoking male subjects between the ages of 20 and 40 years (inclusive);
- Verified diagnosis of "healthy" according to standard clinical, laboratory and instrumental examination methods;
- Body weight from 60 to 95 kg and Body Mass Index from 19.0 to 27.0 kg/m;
- A negative result in tests for alcohol and drugs;
- The subject's consent to use adequate contraception methods during the study and 3 month after end of study: condom with spermicide (foam, gel, cream, suppositories);
Key exclusion criteria (15 listed)
- Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood;
- Variables of standard laboratory and instrumental parameters are beyond the normal limits Variables of standard laboratory and instrumental parameters are beyond the normal limits (taking into account the acceptable limits of laboratory parameters);
- Surgical interventions on the gastrointestinal tract in medical history (except appendectomy);
- Systolic pressure less than 90 mm Mercury or above 130 mm Mercury, diastolic pressure less than 60 mm Mercury or above 85 mm Mercury, heart rate less than 60 BPM or more than 90 BPM at screening;
- Regular intake of drugs less than 2 weeks prior to screening (including herbal preparations and dietary supplements); intake of drugs that have a pronounced effect on hemodynamics, liver function, etc. (for example, barbiturates, omeprazole, cimetidine, etc.) less than 30 days prior to 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 |
|---|---|---|
| VM-1500FDCAlso: VM1500FDCA fixed-dose combination of three active substances: tenofovir 300 mg + elsulfavirine 20 mg + emtricitabine 200 mg, film-coated tablets | Drug | VM-1500FDC |
| Elpida®Also: VM-1500, VM1500, ElsulfavirineElpida®, capsules, elsulfavirine 20 mg | Drug | Elpida® & Truvada® |
| Truvada®Truvada® (tenofovir 300 mg / emtricitabine 200 mg), film-coated tablets | Drug | Elpida® & Truvada® |
Primary outcome
Plasma concentration of VM1500A
Time frame: 29 days
Plasma concentration of elsulfavirine
Time frame: 29 days
Plasma concentration of emtricitabine
Time frame: 29 days
Plasma concentration of tenofovir
Time frame: 29 days
1 secondary outcome
Frequency and severity of AEs and SAEs
Time frame: 29 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 30 Oct 2018.
- Individual participant dataSharing planned: No
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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 Mazygula, PhD principal investigator
Private non - governmental health care institution "Scientific Clinical Center of the open joint - stock company Russian Railways"
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VM-1500FDC, Elpida® and Truvada® 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 6 inclusion and 15 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 30 Oct 2018. 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 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?
Plasma concentration of VM1500A (time frame: 29 days). The study lists 4 primary outcomes in all. 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 30 Oct 2018.