HIV-1-infectionPhase 1NCT03706898
Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs
A Phase 1 study testing Elpida®, Dolutegravir and Sofosbuvir in people with HIV-1-infection and Hepatic Impairment, run by Viriom at 1 site in Russia.
Trial summary
This is open label, phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child - Pugh Class А and B), as well as to assess the impact of food intake and drug-drug interactions in case of Co-administration with other… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection, Hepatic Impairment
- What is being tested?
- Elpida®, Dolutegravir and Sofosbuvir
- 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
- 1 Oct 2018to 10 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking male or female subjects between the ages of 18 and 45 years (inclusive);
- Verified "healthy" diagnosis according to standard clinical, laboratory and instrumental examination methods;
- Body Mass Index ranges between 18.5 kg/m2 and 30.0 kg/m2 and a body weight not less than 50 kg;
- Negative alcohol and drug tests;
- Consent to use two adequate and reliable methods of contraception throughout the study and up to 3 months after its completion: a condom with spermicide (foam, gel, cream, suppositories), or a diaphragm with spermicide, or a condom and diaphragm, or a condom and an intrauterine device;
- Signed Patient Information Sheet and form of Informed Consent to participate in the study.
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- Non-smoking male or female subjects between the ages of 18 and 45 years (inclusive);
- Mild and moderate hepatic impairment (Child - Pugh Class A or B), including viral nature (Hepatitis C virus, etc.). At the same time, there were no changes in the diagnosis of the patient according to Child - Pugh Class not less than 1 month prior to screening;
- Increase in the concentration of aspartate aminotransferase (AST )and (or) alanine aminotransferase (ALT) in blood plasma by 1.25 times or more from the upper limit of the norm (ULN), but not more than 5 times ULN at the time of screening;
- Body Mass Index ranges between 18.0 kg/m2 and 36.0 kg/m2 and a body weight not less than 50 kg, but not more than 120 kg;
- Negative alcohol and drug tests;
- Consent to use two adequate and reliable methods of contraception throughout the study and up to 3 months after its completion: a condom with spermicide (foam, gel, cream, suppositories), or a diaphragm with spermicide, or a condom and diaphragm, or a condom and an intrauterine device;
- Signed Patient Information Sheet and form of Informed Consent to participate in the study.
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 (taking into account the acceptable limits of laboratory parameters);
- Surgical interventions on the gastrointestinal tract in medical history (except appendectomy);
- Systolic pressure below 90 mmHg or above 130 mmHg, diastolic pressure below 60 mmHg or above 85 mmHg, 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, hepatic 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 (intake of 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;
- Drug allergies in medical history (including drug intolerance, including hypersensitivity to active / excipient substances of study drugs - elsulfavirine, sofosbuvir, daclatasvir, dolutegravir as well as any other substance of study drugs ) as well as food allergy;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- Blood/plasma donation (450 ml of blood or plasma and more) less than 2 months prior to screening;
- Participation in other clinical studies or taking other study drugs 1 months prior to screening;
- Acute infectious diseases less than 4 weeks prior to screening;
- Inhibitors or inducers of CYP3A4/5, drugs that cause QTс prolongation () within 30 days prior to Study Drug administration;
- For women - positive result of pregnancy test or breastfeeding;
- 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 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 participate in the study.
- Severe hepatic impairment (Child - Pugh Class C); other hepatic disorders or conditions that do not allow according to the Investigator to include the patient in the study without increased threat to his safety - including (but not limited to) signs of severe ascites requiring regular abdominal laparocentesis, the level of total bilirubin in blood plasma > 100 µmol/l, etc.;
- Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal system, as well as diseases of the gastrointestinal tract, kidneys, blood, requiring medical treatment and preventing, according to the Investigator the subject's participation in the study;
- Surgical interventions on the gastrointestinal tract in medical history including liver transplantation (except appendectomy);
- Regular intake of drugs less than 2 weeks prior to study drug administration (including herbal preparations and dietary supplements); intake of drugs that have a pronounced effect on hemodynamics, hepatic function, etc. (for example, barbiturates, omeprazole, cimetidine, etc.) less than 30 days prior to study drug administration;
- Antibodies to HIV, a positive syphilis test;
- 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;
- Drug allergies in medical history (including drug intolerance, including hypersensitivity to active / excipient substances of Elpida®) as well as food allergy;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- Participation in other clinical studies or taking other study drugs 1 months prior to screening;
- Acute infectious diseases less than 4 weeks prior to screening;
- Any prescribed pharmacotherapy aimed at restoring hepatic function, eradication of hepatitis viruses, or otherwise focused on the compensation of hepatic impairment;
- Administration of inhibitors or inducers of CYP3A4/5, drugs that cause QTс prolongation within 30 days prior to StD administration; ongoing therapy with immunosuppressive agents;
- For women - positive result of pregnancy test or breastfeeding;
- 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 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 participate in the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Regional State Budgetary Healthcare Institution "Smolensk Regional Clinical Hospital"
Smolensk, 214018
About this study
Official title: Open Label Study to Evaluate the Safety and Pharmacokinetics of Elpida® in Healthy Subjects and Patients With Hepatic Impairment, as Well as to Assess the Impact of Food Intake and Drug-Drug Interactions in Case of Co-administration With Other Antiviral Drugs in Healthy Subjects
This is open label, phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child - Pugh Class А and B), as well as to assess the impact of food intake and drug-drug interactions in case of Co-administration with other antiviral drugs in healthy subjects.
Read the detailed description
In medical practice HIV infection is often found associated with viral hepatitis, especially chronic hepatitis C virus (HCV). This, as well as a possible change in PK parameters in case of co-administration of Elpida® and HIV integrase inhibitors, necessitates the study of PK and safety of co-administration of Elpida® with a combination of Sofosbuvir + Daclatasvir and Dolutegravir in healthy subjects. Thus, the study to evaluates safety and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment, as well as assesses the impact of food intake and drug-drug interactions in case of co-administration with other antiviral drugs in healthy subjects.
- Conditions
- HIV-1-infection, Hepatic Impairment
- Being tested
- Elpida®, Dolutegravir, Sofosbuvir, Daclatasvir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elpida®Drug
Also called Elsulfavirine, VM1500, VM-1500
Elpida® capsules, 20mg
DolutegravirDrug
Also called TIVICAY®
Dolutegravir, film-coated tablets, 50mg
SofosbuvirDrug
Also called Sovaldi
Sofosbuvir, film-coated tablets, 400mg
DaclatasvirDrug
Also called Daklinza®
Daclatasvir, film-coated tablets, 60mg
| Study group | Role | What they receive |
|---|---|---|
| Elpida® fasting | Experimental | Elpida® 20 mg single dose fasting Receives: Drug: Elpida® |
| Elpida® after meal | Experimental | Elpida® 20 mg single dose after meals Receives: Drug: Elpida® |
| Elpida® (in subjects with mild hepatic impairment) | Experimental | Elpida® 20 mg single dose fasting - subjects with mild hepatic impairment (Child - Pugh Class А) Receives: Drug: Elpida® |
| Elpida® (in subjects with moderate hepatic impairment) | Experimental | Elpida® 20 mg single dose fasting - subjects with moderate hepatic impairment (Child - Pugh Class B) Receives: Drug: Elpida® |
| Elpida® & sofosbuvir & daclatasvir | Experimental | Drug-drug interactions of sofosbuvir 400 mg + daclatasvir 60 mg and Elpida® 20 mg, single dose fasting Receives: Drug: Elpida®; Drug: Sofosbuvir; Drug: Daclatasvir |
| Elpida® & dolutegravir | Experimental | Drug-drug interactions of dolutegravir 50 mg and Elpida® 20 mg, single dose fasting Receives: Drug: Elpida®; Drug: Dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of elsulfavirine
Measured: 42 days
Plasma concentration of VM-1500A
Measured: 42 days
Plasma concentration of daclatasvir
Measured: 42 days
Plasma concentration of sofosbuvir
Measured: 42 days
Plasma concentration of dolutegravir
Measured: 42 days
Secondary outcomes (1)
AEs and SAEs frequency
Adverse events (AE) and serious adverse events (SAE) frequency of varying severity according to subjective complaints, physical examination, instrumental and laboratory studies
Measured: 42 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 Oct 2018
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viriom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alla Andreeva, PhD, Principal investigator, Regional State Budgetary Healthcare Institution "Smolensk Regional Clinical Hospital"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706898
- Sponsor's protocol ID
- HIV-VM1500-07
- Status last verified
- May 2020
- First submitted
- 11 Oct 2018
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Evaluate the Safety and Pharmacokinetics of Elpida® in Healthy Subjects and Patients With Hepatic Impairment, as Well as to Assess the Impact of Food Intake and Drug-Drug Interactions in Case of Co-administration With Other Antiviral Drugs in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03706898
- Acronym / sponsor ID
- HIV-VM1500-07
- Conditions
- HIV-1-infection, Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ViriomIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (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.
This is open label, phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child - Pugh Class А and B), as well as to assess the impact of food intake and drug-drug interactions in case of Co-administration with other antiviral drugs in healthy subjects.
Detailed description
In medical practice HIV infection is often found associated with viral hepatitis, especially chronic hepatitis C virus (HCV). This, as well as a possible change in PK parameters in case of co-administration of Elpida® and HIV integrase inhibitors, necessitates the study of PK and safety of co-administration of Elpida® with a combination of Sofosbuvir + Daclatasvir and Dolutegravir in healthy subjects. Thus, the study to evaluates safety and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment, as well as assesses the impact of food intake and drug-drug interactions in case of co-administration with other antiviral drugs in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Elpida® fasting | Experimental | Drug: Elpida®Elpida® 20 mg single dose fasting |
| Elpida® after meal | Experimental | Drug: Elpida®Elpida® 20 mg single dose after meals |
| Elpida® (in subjects with mild hepatic impairment) | Experimental | Drug: Elpida®Elpida® 20 mg single dose fasting - subjects with mild hepatic impairment (Child - Pugh Class А) |
| Elpida® (in subjects with moderate hepatic impairment) | Experimental | Drug: Elpida®Elpida® 20 mg single dose fasting - subjects with moderate hepatic impairment (Child - Pugh Class B) |
| Elpida® & sofosbuvir & daclatasvir | Experimental | Drug: Elpida®, Drug: Sofosbuvir, Drug: DaclatasvirDrug-drug interactions of sofosbuvir 400 mg + daclatasvir 60 mg and Elpida® 20 mg, single dose fasting |
| Elpida® & dolutegravir | Experimental | Drug: Elpida®, Drug: DolutegravirDrug-drug interactions of dolutegravir 50 mg and Elpida® 20 mg, single dose fasting |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Non-smoking male or female subjects between the ages of 18 and 45 years (inclusive);
- Verified "healthy" diagnosis according to standard clinical, laboratory and instrumental examination methods;
- Body Mass Index ranges between 18.5 kg/m2 and 30.0 kg/m2 and a body weight not less than 50 kg;
- Negative alcohol and drug tests;
- Consent to use two adequate and reliable methods of contraception throughout the study and up to 3 months after its completion: a condom with spermicide (foam, gel, cream, suppositories), or a diaphragm with spermicide, or a condom and diaphragm, or a condom and an intrauterine device;
Key exclusion criteria (31 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 (taking into account the acceptable limits of laboratory parameters);
- Surgical interventions on the gastrointestinal tract in medical history (except appendectomy);
- Systolic pressure below 90 mmHg or above 130 mmHg, diastolic pressure below 60 mmHg or above 85 mmHg, 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, hepatic 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 |
|---|---|---|
| Elpida®Also: Elsulfavirine, VM1500, VM-1500Elpida® capsules, 20mg | Drug | Elpida® & dolutegravir, Elpida® & sofosbuvir & daclatasvir, Elpida® (in subjects with mild hepatic impairment), Elpida® (in subjects with moderate hepatic impairment), Elpida® after meal, Elpida® fasting |
| DolutegravirAlso: TIVICAY®Dolutegravir, film-coated tablets, 50mg | Drug | Elpida® & dolutegravir |
| SofosbuvirAlso: SovaldiSofosbuvir, film-coated tablets, 400mg | Drug | Elpida® & sofosbuvir & daclatasvir |
| DaclatasvirAlso: Daklinza®Daclatasvir, film-coated tablets, 60mg | Drug | Elpida® & sofosbuvir & daclatasvir |
Primary outcome
Plasma concentration of elsulfavirine
Time frame: 42 days
Plasma concentration of VM-1500A
Time frame: 42 days
Plasma concentration of daclatasvir
Time frame: 42 days
Plasma concentration of sofosbuvir
Time frame: 42 days
Plasma concentration of dolutegravir
Time frame: 42 days
1 secondary outcome
AEs and SAEs frequency
Time frame: 42 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 11 Jan 2022.
- 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.
Alla Andreeva, PhD principal investigator
Regional State Budgetary Healthcare Institution "Smolensk Regional Clinical Hospital"
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®, Dolutegravir and Sofosbuvir in people with HIV-1-infection and Hepatic Impairment, 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 13 inclusion and 31 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 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?
Plasma concentration of elsulfavirine (time frame: 42 days). The study lists 5 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 11 Jan 2022.