HIV-1-infectionNCT03706950
Post-approval Observational Study of Elpida® in the First Line Therapy for HIV-1 Infected Patients With Background Standard ART
An observational study of HIV-1-infection, run by Viriom at 11 sites in Russia.
Trial summary
This post-registration observational study is designed to monitor the safety parameters and efficacy of Elpida® in actual practice in the first-line treatment of HIV-1 infected patients on the background of the standard baseline ART. 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?
- Elpida® + 2 NRTIs
- Type of treatment
- Pill or oral medicine
- How many people
- 2,000 participants
- Where
- 11 sitesRussia
- Study dates
- 15 Mar 2018to 31 Dec 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: In total, 2000 HIV-1-infected patients who are prescribed therapy with Elpida® (20 mg capsules) against the background of standard baseline ART are planned to be included in the observational study. The study will enroll patients who are ART-naive or are transferred to Elpida® from other first-line ART regimens because of intolerance.
Who may be able to join
- A signed patient information sheet and a form of informed consent to participate in the study.
- Men and women aged 18 and over.
- Document supported HIV-1 infection.
- Patients whom during the previous 24 weeks first line ART was prescried comprising the drug Elpida®, including patients who are ART-naive or were transferred to Elpida® from other first line ART regimens due to intolerance (transfer from other NNRTIs - within the class; transfer from protease inhibitors, including boosted ones, due to lipid metabolism disorders or other adverse reactions (AR) if the virological effectiveness of the previous ART regimen - was effective - reaching undetectable levels of viral load).
Who cannot join
- Current participation in the clinical trial.
- Significant alcohol and/(or) drug dependence, which, according to the researcher, can prevent collection of data.
- Increase of AST/ALT levels by more than 2.5 times higher than the upper limit of the reference range at Week 0 visit.
- Replication stage of chronic hepatitis C (presence of HCV RNA), requiring therapy.
- Use of Elpida® in violation of indications officially approved by the Ministry of Health of the Russian Federation on the package leaflet.
- Significant secondary diseases requiring treatment.
Trial locations and contacts
11 sites in 1 country.
Natalia Vostokova, PhD contact
11 sites in 1 country
Russia11 sites, 11 recruiting
- Recruiting
Regional AIDS Prevention and Control Center
Astrakhan, 414041
Baburina Albina, +78512520066, 76alb76@gmail.com
- Recruiting
Altai Regional Center for the Prevention and Control of AIDS and Infectious Diseases
Barnaul, 656010
Novikova Olga, 8(905)987-64-36, a090@yandex.ru
- Recruiting
Regional Center for the Prevention and Control of AIDS and Infectious Diseases
Chelyabinsk, 454038
Radzikhovskaya Margarit, 83512149901, rita-rad@mail.ru
- Recruiting
Center for AIDS Prevention and Control
Gorno-Altaysk, 649002
Ul'chiekova Marina, 8(388-22) 2-20-78, amb.vich@yandex.ru
- Recruiting
Center for the Prevention and Control of AIDS and Infectious Diseases
Khabarovsk, 680031
Kuznetsova Anna, 8-962-220-36-01, avkuznecova@bk.ru
- Recruiting
Clinical Center for AIDS Prevention and Control
Krasnodar, 350015
Palaguta Alexander, +7(861)2536454, palaguta2000@mail.ru
- Recruiting
The State Budgetary Healthcare Institution of Moscow "Infectious Clinical Hospital No. 2 of the Moscow City Health Department" (SGBU ICD No. 2 DZM), Moscow City Center for AIDS Prevention and Control of the Moscow City Health Department
Moscow, 105275
Shimonova Tatiana, Ph.D, 8(495)3666238, tshimonova@mail.ru
- Recruiting
State Regional Clinical Hospital "City Infectious Clinical Hospital No. 1"
Novosibirsk, 630099
Ulyanov Yana, 8-913-920-18-87, yanaulyanova@mail.ru
- Recruiting
Center for AIDS Prevention and Control
Rostov-on-Don, 344116
Fisenko Ekaterina, 8 (8632) 18-55-37, fisenkoeg@gmail.com
- Recruiting
State Public Health Institution of the Leningrad Region "Center for the Prevention and Control of AIDS and Infectious Diseases"
Saint Petersburg, 190020
Isaeva Galina, 8-921-384-05-00, G.N.Isaeva@yandex.ru
- Recruiting
St. Petersburg State Budgetary Healthcare Institution "Center for the Prevention and Control of AIDS and Infectious Diseases"
Saint Petersburg, 190103
Sizova Natalia, 8-911-723-12-54, natalia_v_sizova@mail.ru
About this study
Official title: Multicentre, Open-label, Post-approval Observational Study of Elpida® Used in the First Line Therapy for HIV-1 Infected Patients With the Background of Standard Baseline ART (NNRTI + 2 NRTIs)
This post-registration observational study is designed to monitor the safety parameters and efficacy of Elpida® in actual practice in the first-line treatment of HIV-1 infected patients on the background of the standard baseline ART.
Read the detailed description
This study is a multicenter, open-label, post-registration observational non-interventional study of the use of Elpida® in the first line of therapy for HIV-1 infected patients against a background of standard baseline ART (NNRTIs + 2 NRTIs). The study is scheduled to be conducted approximately in 20 centers for the prevention and control of AIDS in Russia.
In total, 2000 HIV-1-infected patients who are prescribed therapy with Elpida® (20 mg capsules) against the background of standard baseline ART are planned to be included in the study.
The observational study will collect data from patients who signed informed consent and meet all inclusion/non-inclusion criteria from the time that precedes the therapy by Elpida® up to 96 weeks of treatment or until early elimination. The data will be obtained through routine visits and procedures, including demographics and history, height, body weight, body mass index (BMI), laboratory data (viral load of HIV-1, CD4+-T-lymphocytes, resistance mutations in HIV-1, screening for hepatitis B and C, syphilis, general and biochemical blood analysis, general urine analysis) and instrumental examinations (electrocardiography (ECG), chest X-ray/fluorography). Throughout the study, patients will keep observation diaries for recording AEs and concomitant therapy. Data on the intake of ART drugs and AE related to their use will also be collected.
- Conditions
- HIV-1-infection
- Being tested
- Elpida® + 2 NRTIs
- Keywords
- HIV-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elpida® + 2 NRTIsDrug
Elpida® 20mg qd orally + 2 NRTIs standard prescribed ART therapy
| Study group | Role | What they receive |
|---|---|---|
| Elpida® + 2 NRTIs | Elpida® 20mg qd in the first line of therapy for HIV-1 infected patients with a background standard ART. Receives: Drug: Elpida® + 2 NRTIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs and SAEs
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: 96 weeks
Secondary outcomes (5)
Viral load
Dynamics of viral load (HIV RNA) in blood plasma
Measured: 96 weeks
Proportion of patients with undetectable viral load on visits, starting from Week 24
Proportion of patients with undetectable viral load (HIV-1 RNA level in blood plasma < 50 copies / ml or, at least 400 copies / ml depending on assessment method sensitivity in the clinical site) on visits, starting from Week 24
Measured: 24 weeks
The frequency of virological failures
The frequency of virological failures, including incomplete suppression or the resumption of viral load
Measured: 96 weks
Absolute CD8+ lymphocytes count
Change in the absolute CD8+ lymphocytes count
Measured: 96 weeks
The percent of patients who developed HIV-1 resistance to Elpida®
The proportion of patients who develop study therapy-resistant HIV-1. An assessment of the development of HIV-1 resistance to antiretroviral drugs should be carried out if treatment failure is registered. Treatment failure is determined after at least 24 weeks of therapy, if in two consecutive measurements with an interval of 12 weeks the viral load exceeds 1000 copies / ml providing patient complience with ART recommendations
Measured: 96 weeks
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 start15 Mar 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viriom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena Yakubova, PhD, Study director, Viriom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706950
- Sponsor's protocol ID
- HIV-VM1500-06
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2018
- Last updated
- 18 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 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Open-label, Post-approval Observational Study of Elpida® Used in the First Line Therapy for HIV-1 Infected Patients With the Background of Standard Baseline ART (NNRTI + 2 NRTIs)
- ClinicalTrials.gov ID
- NCT03706950
- Acronym / sponsor ID
- HIV-VM1500-06
- Conditions
- HIV-1-infection
- Keywords
- HIV-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- ViriomIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- 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 post-registration observational study is designed to monitor the safety parameters and efficacy of Elpida® in actual practice in the first-line treatment of HIV-1 infected patients on the background of the standard baseline ART.
Detailed description
This study is a multicenter, open-label, post-registration observational non-interventional study of the use of Elpida® in the first line of therapy for HIV-1 infected patients against a background of standard baseline ART (NNRTIs + 2 NRTIs). The study is scheduled to be conducted approximately in 20 centers for the prevention and control of AIDS in Russia.
In total, 2000 HIV-1-infected patients who are prescribed therapy with Elpida® (20 mg capsules) against the background of standard baseline ART are planned to be included in the study.
The observational study will collect data from patients who signed informed consent and meet all inclusion/non-inclusion criteria from the time that precedes the therapy by Elpida® up to 96 weeks of treatment or until early elimination. The data will be obtained through routine visits and procedures, including demographics and history, height, body weight, body mass index (BMI), laboratory data (viral load of HIV-1, CD4+-T-lymphocytes, resistance mutations in HIV-1, screening for hepatitis B and C, syphilis, general and biochemical blood analysis, general urine analysis) and instrumental examinations (electrocardiography (ECG), chest X-ray/fluorography). Throughout the study, patients will keep observation diaries for recording AEs and concomitant therapy. Data on the intake of ART drugs and AE related to their use will also be collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elpida® + 2 NRTIs | – | Drug: Elpida® + 2 NRTIsElpida® 20mg qd in the first line of therapy for HIV-1 infected patients with a background standard ART. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In total, 2000 HIV-1-infected patients who are prescribed therapy with Elpida® (20 mg capsules) against the background of standard baseline ART are planned to be included in the observational study. The study will enroll patients who are ART-naive or are transferred to Elpida® from other first-line ART regimens because of intolerance.
Key inclusion criteria (4 listed)
- A signed patient information sheet and a form of informed consent to participate in the study.
- Men and women aged 18 and over.
- Document supported HIV-1 infection.
- Patients whom during the previous 24 weeks first line ART was prescried comprising the drug Elpida®, including patients who are ART-naive or were transferred to Elpida® from other first line ART regimens due to intolerance (transfer from other NNRTIs - within the class; transfer from protease inhibitors, including boosted ones, due to lipid metabolism disorders or other adverse reactions (AR) if the virological effectiveness of the previous ART regimen - was effective - reaching undetectable levels of viral load).
Key exclusion criteria (6 listed)
- Current participation in the clinical trial.
- Significant alcohol and/(or) drug dependence, which, according to the researcher, can prevent collection of data.
- Increase of AST/ALT levels by more than 2.5 times higher than the upper limit of the reference range at Week 0 visit.
- Replication stage of chronic hepatitis C (presence of HCV RNA), requiring therapy.
- Use of Elpida® in violation of indications officially approved by the Ministry of Health of the Russian Federation on the package leaflet.
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® + 2 NRTIsElpida® 20mg qd orally + 2 NRTIs standard prescribed ART therapy | Drug | Elpida® + 2 NRTIs |
Primary outcome
Incidence of AEs and SAEs
Time frame: 96 weeks
Incidence of adverse events (AEs) and serious adverse events (SAEs)
5 secondary outcomes
Viral load
Time frame: 96 weeks
Proportion of patients with undetectable viral load on visits, starting from Week 24
Time frame: 24 weeks
The frequency of virological failures
Time frame: 96 weks
Absolute CD8+ lymphocytes count
Time frame: 96 weeks
The percent of patients who developed HIV-1 resistance to Elpida®
Time frame: 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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.
Natalia Vostokova, PhD contact
Elena Yakubova, PhD study director
Viriom
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by Viriom at 11 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 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 11 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Yakubova, PhD (+7 (495) 995-49-44, ey@chemrar.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs and SAEs (time frame: 96 weeks). 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 18 Oct 2018; AzTrials last refreshed its copy on 5 Nov 2026.