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

Last updated: October 15, 2018
Sponsor: Viriom
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03706950
HIV-VM1500-06
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. A signed patient information sheet and a form of informed consent to participate inthe 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 thedrug Elpida®, including patients who are ART-naive or were transferred to Elpida® fromother first line ART regimens due to intolerance (transfer from other NNRTIs - withinthe class; transfer from protease inhibitors, including boosted ones, due to lipidmetabolism disorders or other adverse reactions (AR) if the virological effectivenessof the previous ART regimen - was effective - reaching undetectable levels of viralload).

Exclusion

Exclusion Criteria:

  1. Current participation in the clinical trial.

  2. Significant alcohol and/(or) drug dependence, which, according to the researcher, canprevent collection of data.

  3. Increase of AST/ALT levels by more than 2.5 times higher than the upper limit of thereference 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 ofHealth of the Russian Federation on the package leaflet.

  6. Significant secondary diseases requiring treatment.

Study Design

Total Participants: 2000
Study Start date:
March 15, 2018
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Regional AIDS Prevention and Control Center

    Astrakhan, 414041
    Russian Federation

    Active - Recruiting

  • Altai Regional Center for the Prevention and Control of AIDS and Infectious Diseases

    Barnaul, 656010
    Russian Federation

    Active - Recruiting

  • Regional Center for the Prevention and Control of AIDS and Infectious Diseases

    Chelyabinsk, 454038
    Russian Federation

    Active - Recruiting

  • Center for AIDS Prevention and Control

    Gorno-Altaisk, 649002
    Russian Federation

    Active - Recruiting

  • Center for the Prevention and Control of AIDS and Infectious Diseases

    Khabarovsk, 680031
    Russian Federation

    Active - Recruiting

  • Clinical Center for AIDS Prevention and Control

    Krasnodar, 350015
    Russian Federation

    Active - 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
    Russian Federation

    Active - Recruiting

  • State Regional Clinical Hospital "City Infectious Clinical Hospital No. 1"

    Novosibirsk, 630099
    Russian Federation

    Active - Recruiting

  • Center for AIDS Prevention and Control

    Rostov-on-Don, 344116
    Russian Federation

    Active - Recruiting

  • St. Petersburg State Budgetary Healthcare Institution "Center for the Prevention and Control of AIDS and Infectious Diseases"

    Saint Petersburg, 190103
    Russian Federation

    Active - Recruiting

  • State Public Health Institution of the Leningrad Region "Center for the Prevention and Control of AIDS and Infectious Diseases"

    Saint Petersburg, 190020
    Russian Federation

    Active - Recruiting

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