Post-approval Observational Study of Elpida® in the First Line Therapy for HIV-1 Infected Patients With Background Standard ART
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)
1 other identifier
observational
2,000
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2018
CompletedFirst Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
October 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedOctober 18, 2018
October 1, 2018
3.8 years
October 11, 2018
October 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of AEs and SAEs
Incidence of adverse events (AEs) and serious adverse events (SAEs)
96 weeks
Secondary Outcomes (5)
Viral load
96 weeks
Proportion of patients with undetectable viral load on visits, starting from Week 24
24 weeks
The frequency of virological failures
96 weks
Absolute CD8+ lymphocytes count
96 weeks
The percent of patients who developed HIV-1 resistance to Elpida®
96 weeks
Study Arms (1)
Elpida® + 2 NRTIs
Elpida® 20mg qd in the first line of therapy for HIV-1 infected patients with a background standard ART.
Interventions
Elpida® 20mg qd orally + 2 NRTIs standard prescribed ART therapy
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viriomlead
Study Sites (11)
Regional AIDS Prevention and Control Center
Astrakhan, 414041, Russia
Altai Regional Center for the Prevention and Control of AIDS and Infectious Diseases
Barnaul, 656010, Russia
Regional Center for the Prevention and Control of AIDS and Infectious Diseases
Chelyabinsk, 454038, Russia
Center for AIDS Prevention and Control
Gorno-Altaysk, 649002, Russia
Center for the Prevention and Control of AIDS and Infectious Diseases
Khabarovsk, 680031, Russia
Clinical Center for AIDS Prevention and Control
Krasnodar, 350015, Russia
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, Russia
State Regional Clinical Hospital "City Infectious Clinical Hospital No. 1"
Novosibirsk, 630099, Russia
Center for AIDS Prevention and Control
Rostov-on-Don, 344116, Russia
State Public Health Institution of the Leningrad Region "Center for the Prevention and Control of AIDS and Infectious Diseases"
Saint Petersburg, 190020, Russia
St. Petersburg State Budgetary Healthcare Institution "Center for the Prevention and Control of AIDS and Infectious Diseases"
Saint Petersburg, 190103, Russia
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Elena Yakubova, PhD
Viriom
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2018
First Posted
October 16, 2018
Study Start
March 15, 2018
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
October 18, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share