HIV-1-infectionPhase 1NCT03709355
Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs
A Phase 1 study testing Elpida®, Rifampin and Rifabutin in people with HIV-1-infection, run by Viriom at 1 site in Russia.
Trial summary
The study assesses PK and safety of other drugs, such as some antibiotics, proton pump inhibitors, statins, and combined oral contraceptives when co-administered with Elpida® 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
- What is being tested?
- Elpida®, Rifampin and Rifabutin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteRussia
- Study dates
- 14 Nov 2018to 6 Sep 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
- Healthy subjects must meet the following criteria to be enrolled in the study:
- Non-smoking men and women between the ages of 18 and 45 years (inclusive) (only women in Group 7);
- 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 NLT 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.
Who cannot join
- A subject will be considered not eligible to participate in the study if one or more of the following criteria is met:
- 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 mm Mercury or above 130 mm Mercury, diastolic pressure below 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, hepatic function, etc. (for example, barbiturates, omeprazole, cimetidine, etc.) less than 30 days prior to screening;
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- Presence of antibodies to HIV and hepatitis C virus, presence of hepatitis В surface antigen, 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 (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 any components of study drugs) as well as food allergy;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- Individual intolerance to any components of 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 1 month prior to screening (including follow-up visits);
- Acute infectious diseases less than 4 weeks prior to screening;
- Inhibitors or inducers of CYP3A4/5, drugs that cause QT prolongation within 30 days prior to StD 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of ELPIDA® in Co-Administration With Other Drugs in Healthy Volunteers
The study assesses PK and safety of other drugs, such as some antibiotics, proton pump inhibitors, statins, and combined oral contraceptives when co-administered with Elpida®
Read the detailed description
This study evaluates the drug-drug interaction of Elpida® and other drugs (Rifampin, Rifabutin, Clarithromycin, Omeprazole, Atorvastatin and combinations of Levonorgestrel and Ethinylestradiol) according to changes in the PK parameters of the study substances in their single co-administration in healthy subjects
- Conditions
- HIV-1-infection
- Being tested
- Elpida®, Rifampin, Rifabutin, Clarithromycin, Omeprazole
- Keywords
- HIV-1
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
RifampinDrug
Rifampin capsules, 150mg
RifabutinDrug
Rifabutin capsules, 150mg
ClarithromycinDrug
Clarithromycin Film-coated tablets, 250mg
OmeprazoleDrug
Omeprazole Film-coated tablets 20mg
AtorvastatinDrug
Atorvastatin Film-coated tablets, 80mg
Levonorgestrel+EthinylestradiolDrug
Levonorgestrel 150 μg + Ethinylestradiol 30 μg, Film-coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Elpida® single dose | Active comparator | Single dose of Elpida® (capsule 20 mg) Receives: Drug: Elpida® |
| Rifampin & Elpida® | Experimental | Single dose of Rifampin (capsule 150 mg), Rifampin + Elpida® 20mg single dose Receives: Drug: Elpida®; Drug: Rifampin |
| Rifabutin & Elpida® | Experimental | Single dose of Rifabutin capsule 150 mg, Rifabutin + Elpida® 20mg single dose Receives: Drug: Elpida®; Drug: Rifabutin |
| Clarithromycin & Elpida® | Experimental | Single dose of Clarithromycin capsule 250 mg, Clarithromycin + Elpida® 20mg single dose Receives: Drug: Elpida®; Drug: Clarithromycin |
| Omeprazole & Elpida® | Experimental | Single dose of Omeprazole capsule 20 mg, Omeprazole + Elpida® 20mg single dose Receives: Drug: Elpida®; Drug: Omeprazole |
| Atorvastatin & Elpida® | Experimental | Single dose of Atorvastatin tablet 80 mg, Atorvastatin + Elpida® 20mg single dose Receives: Drug: Elpida®; Drug: Atorvastatin |
| Levonorgestrel+Ethinylestradiol & Elpida® | Experimental | Single dose of Levonorgestrel 150 µg + Ethinylestradiol 150 µg tablet, Levonorgestrel + Ethinylestradiol + Elpida® 20mg single dose Receives: Drug: Elpida®; Drug: Levonorgestrel+Ethinylestradiol |
| Elpida® multiple dose | Active comparator | Elpida® QD dosing for 14 days Receives: Drug: Elpida® |
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 VM1500A
Measured: 42 days
Plasma concentration of rifampicin
Measured: 42 days
Plasma concentration of rifabutin
Measured: 49 days
Plasma concentration of clarithromycin
Measured: 42 days
Plasma concentration of atorvastatin
Measured: 42 days
Plasma concentration of levonorgestrel
Measured: 42 days
Plasma concentration of ethinylestradiol
Measured: 42 days
Secondary outcomes (1)
The incidence of AEs and SAEs
Measured: 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start14 Nov 2018
- Primary completion6 Sep 2019
- Study completion6 Sep 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viriom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena Smolyarchuk, PhD, Principal investigator, I.M. Sechenov First Medical State UniversityAlla Andreeva, PhD, Principal investigator, Smolensk Region Clinical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709355
- Sponsor's protocol ID
- HIV-VM1500-08
- Status last verified
- Jan 2022
- First submitted
- 11 Oct 2018
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of ELPIDA® in Co-Administration With Other Drugs in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03709355
- Acronym / sponsor ID
- HIV-VM1500-08
- Conditions
- HIV-1-infection
- Keywords
- HIV-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- ViriomIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 17 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.
The study assesses PK and safety of other drugs, such as some antibiotics, proton pump inhibitors, statins, and combined oral contraceptives when co-administered with Elpida®
Detailed description
This study evaluates the drug-drug interaction of Elpida® and other drugs (Rifampin, Rifabutin, Clarithromycin, Omeprazole, Atorvastatin and combinations of Levonorgestrel and Ethinylestradiol) according to changes in the PK parameters of the study substances in their single co-administration in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Elpida® single dose | Active comparator | Drug: Elpida®Single dose of Elpida® (capsule 20 mg) |
| Rifampin & Elpida® | Experimental | Drug: Elpida®, Drug: RifampinSingle dose of Rifampin (capsule 150 mg), Rifampin + Elpida® 20mg single dose |
| Rifabutin & Elpida® | Experimental | Drug: Elpida®, Drug: RifabutinSingle dose of Rifabutin capsule 150 mg, Rifabutin + Elpida® 20mg single dose |
| Clarithromycin & Elpida® | Experimental | Drug: Elpida®, Drug: ClarithromycinSingle dose of Clarithromycin capsule 250 mg, Clarithromycin + Elpida® 20mg single dose |
| Omeprazole & Elpida® | Experimental | Drug: Elpida®, Drug: OmeprazoleSingle dose of Omeprazole capsule 20 mg, Omeprazole + Elpida® 20mg single dose |
| Atorvastatin & Elpida® | Experimental | Drug: Elpida®, Drug: AtorvastatinSingle dose of Atorvastatin tablet 80 mg, Atorvastatin + Elpida® 20mg single dose |
| Levonorgestrel+Ethinylestradiol & Elpida® | Experimental | Drug: Elpida®, Drug: Levonorgestrel+EthinylestradiolSingle dose of Levonorgestrel 150 µg + Ethinylestradiol 150 µg tablet, Levonorgestrel + Ethinylestradiol + Elpida® 20mg single dose |
| Elpida® multiple dose | Active comparator | Drug: Elpida®Elpida® QD dosing for 14 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Non-smoking men and women between the ages of 18 and 45 years (inclusive) (only women in Group 7);
- 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 NLT 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 (17 listed)
- A subject will be considered not eligible to participate in the study if one or more of the following criteria is met:
- 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 mm Mercury or above 130 mm Mercury, diastolic pressure below 60 mm Mercury or above 85 mm Mercury, heart rate less than 60 BPM or more 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 |
|---|---|---|
| Elpida®Also: elsulfavirine, VM1500, VM-1500Elpida® capsules, 20mg | Drug | Atorvastatin & Elpida®, Clarithromycin & Elpida®, Elpida® multiple dose, Elpida® single dose, Levonorgestrel+Ethinylestradiol & Elpida®, Omeprazole & Elpida®, Rifabutin & Elpida®, Rifampin & Elpida® |
| RifampinRifampin capsules, 150mg | Drug | Rifampin & Elpida® |
| RifabutinRifabutin capsules, 150mg | Drug | Rifabutin & Elpida® |
| ClarithromycinClarithromycin Film-coated tablets, 250mg | Drug | Clarithromycin & Elpida® |
| OmeprazoleOmeprazole Film-coated tablets 20mg | Drug | Omeprazole & Elpida® |
| AtorvastatinAtorvastatin Film-coated tablets, 80mg | Drug | Atorvastatin & Elpida® |
| Levonorgestrel+EthinylestradiolLevonorgestrel 150 μg + Ethinylestradiol 30 μg, Film-coated tablets | Drug | Levonorgestrel+Ethinylestradiol & Elpida® |
Primary outcome
Plasma concentration of elsulfavirine
Time frame: 42 days
Plasma concentration of VM1500A
Time frame: 42 days
Plasma concentration of rifampicin
Time frame: 42 days
Plasma concentration of rifabutin
Time frame: 49 days
Plasma concentration of clarithromycin
Time frame: 42 days
Plasma concentration of atorvastatin
Time frame: 42 days
Plasma concentration of levonorgestrel
Time frame: 42 days
Plasma concentration of ethinylestradiol
Time frame: 42 days
1 secondary outcome
The incidence of AEs and SAEs
Time frame: 49 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 26 Jan 2022.
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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, PhD principal investigator
I.M. Sechenov First Medical State University
Alla Andreeva, PhD principal investigator
Smolensk Region 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®, Rifampin and Rifabutin in people with HIV-1-infection, 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 7 inclusion and 17 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 26 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 8 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 26 Jan 2022.