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Post-approval Observational Study of Elpida® in the First Line Therapy for HIV-1 Infected Patients With Background Standard ART

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ClinicalTrials.gov Identifier: NCT03706950
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Viriom

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.

Condition or disease Intervention/treatment
HIV-1-infection Drug: Elpida® + 2 NRTIs

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.


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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
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)
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Elpida® + 2 NRTIs
Elpida® 20mg qd in the first line of therapy for HIV-1 infected patients with a background standard ART.
Drug: Elpida® + 2 NRTIs
Elpida® 20mg qd orally + 2 NRTIs standard prescribed ART therapy




Primary Outcome Measures :
  1. Incidence of AEs and SAEs [ Time Frame: 96 weeks ]
    Incidence of adverse events (AEs) and serious adverse events (SAEs)


Secondary Outcome Measures :
  1. Viral load [ Time Frame: 96 weeks ]
    Dynamics of viral load (HIV RNA) in blood plasma

  2. Proportion of patients with undetectable viral load on visits, starting from Week 24 [ Time Frame: 24 weeks ]
    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

  3. The frequency of virological failures [ Time Frame: 96 weks ]
    The frequency of virological failures, including incomplete suppression or the resumption of viral load

  4. Absolute CD8+ lymphocytes count [ Time Frame: 96 weeks ]
    Change in the absolute CD8+ lymphocytes count

  5. The percent of patients who developed HIV-1 resistance to Elpida® [ Time Frame: 96 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  1. A signed patient information sheet and a form of informed consent to participate in the study.
  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:

  1. Current participation in the clinical trial.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706950


Contacts
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Contact: Elena Yakubova, PhD +7 (495) 995-49-44 ey@chemrar.ru
Contact: Natalia Vostokova, PhD nv@ipharma.ru

Locations
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Russian Federation
Regional AIDS Prevention and Control Center Recruiting
Astrakhan, Russian Federation, 414041
Contact: Baburina Albina    +78512520066    76alb76@gmail.com   
Altai Regional Center for the Prevention and Control of AIDS and Infectious Diseases Recruiting
Barnaul, Russian Federation, 656010
Contact: Novikova Olga    8(905)987-64-36    a090@yandex.ru   
Regional Center for the Prevention and Control of AIDS and Infectious Diseases Recruiting
Chelyabinsk, Russian Federation, 454038
Contact: Radzikhovskaya Margarit    83512149901    rita-rad@mail.ru   
Center for AIDS Prevention and Control Recruiting
Gorno-Altaisk, Russian Federation, 649002
Contact: Ul'chiekova Marina    8(388-22) 2-20-78    amb.vich@yandex.ru   
Center for the Prevention and Control of AIDS and Infectious Diseases Recruiting
Khabarovsk, Russian Federation, 680031
Contact: Kuznetsova Anna    8-962-220-36-01    avkuznecova@bk.ru   
Clinical Center for AIDS Prevention and Control Recruiting
Krasnodar, Russian Federation, 350015
Contact: Palaguta Alexander    +7(861)2536454    palaguta2000@mail.ru   
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 Recruiting
Moscow, Russian Federation, 105275
Contact: Shimonova Tatiana, Ph.D    8(495)3666238    tshimonova@mail.ru   
State Regional Clinical Hospital "City Infectious Clinical Hospital No. 1" Recruiting
Novosibirsk, Russian Federation, 630099
Contact: Ulyanov Yana    8-913-920-18-87    yanaulyanova@mail.ru   
Center for AIDS Prevention and Control Recruiting
Rostov-on-Don, Russian Federation, 344116
Contact: Fisenko Ekaterina    8 (8632) 18-55-37    fisenkoeg@gmail.com   
State Public Health Institution of the Leningrad Region "Center for the Prevention and Control of AIDS and Infectious Diseases" Recruiting
Saint Petersburg, Russian Federation, 190020
Contact: Isaeva Galina    8-921-384-05-00    G.N.Isaeva@yandex.ru   
St. Petersburg State Budgetary Healthcare Institution "Center for the Prevention and Control of AIDS and Infectious Diseases" Recruiting
Saint Petersburg, Russian Federation, 190103
Contact: Sizova Natalia    8-911-723-12-54    natalia_v_sizova@mail.ru   
Sponsors and Collaborators
Viriom
Investigators
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Study Director: Elena Yakubova, PhD Viriom

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Responsible Party: Viriom
ClinicalTrials.gov Identifier: NCT03706950     History of Changes
Other Study ID Numbers: HIV-VM1500-06
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viriom:
HIV-1