Post-approval Observational Study of Elpida® in the First Line Therapy for HIV-1 Infected Patients With Background Standard ART
NCT ID: NCT03706950
Last Updated: 2018-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2018-03-15
2022-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Elpida® + 2 NRTIs
Elpida® 20mg qd in the first line of therapy for HIV-1 infected patients with a background standard ART.
Elpida® + 2 NRTIs
Elpida® 20mg qd orally + 2 NRTIs standard prescribed ART therapy
Interventions
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Elpida® + 2 NRTIs
Elpida® 20mg qd orally + 2 NRTIs standard prescribed ART therapy
Eligibility Criteria
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Inclusion Criteria
2. Men and women aged 18 and over.
3. Document supported HIV-1 infection.
4. 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).
Exclusion Criteria
2. Significant alcohol and/(or) drug dependence, which, according to the researcher, can prevent collection of data.
3. Increase of AST/ALT levels by more than 2.5 times higher than the upper limit of the reference range at Week 0 visit.
4. Replication stage of chronic hepatitis C (presence of HCV RNA), requiring therapy.
5. Use of Elpida® in violation of indications officially approved by the Ministry of Health of the Russian Federation on the package leaflet.
6. Significant secondary diseases requiring treatment.
18 Years
ALL
No
Sponsors
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Viriom
INDUSTRY
Responsible Party
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Principal Investigators
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Elena Yakubova, PhD
Role: STUDY_DIRECTOR
Viriom
Locations
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Regional AIDS Prevention and Control Center
Astrakhan, , Russia
Altai Regional Center for the Prevention and Control of AIDS and Infectious Diseases
Barnaul, , Russia
Regional Center for the Prevention and Control of AIDS and Infectious Diseases
Chelyabinsk, , Russia
Center for AIDS Prevention and Control
Gorno-Altaysk, , Russia
Center for the Prevention and Control of AIDS and Infectious Diseases
Khabarovsk, , Russia
Clinical Center for AIDS Prevention and Control
Krasnodar, , 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, , Russia
State Regional Clinical Hospital "City Infectious Clinical Hospital No. 1"
Novosibirsk, , Russia
Center for AIDS Prevention and Control
Rostov-on-Don, , Russia
State Public Health Institution of the Leningrad Region "Center for the Prevention and Control of AIDS and Infectious Diseases"
Saint Petersburg, , Russia
St. Petersburg State Budgetary Healthcare Institution "Center for the Prevention and Control of AIDS and Infectious Diseases"
Saint Petersburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HIV-VM1500-06
Identifier Type: -
Identifier Source: org_study_id
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