Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified October 2018 by Viriom

Sponsor
Viriom


Information provided by (Responsible Party)
Viriom
ClinicalTrials.gov Identifier
NCT03706950

First received: October 11, 2018
Last updated: October 15, 2018
Last Verified: October 2018
History of Changes
Purpose

Purpose

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 Intervention
HIV-1-infection

Drug : Elpida® + 2 NRTIs

Study Type: Observational
Study Design: 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)

Further study details as provided by Viriom:

Primary Outcome Measures

  • Incidence of AEs and SAEs [ Time Frame: 96 weeks ]
    Incidence of adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcome Measures:
  • Viral load [ Time Frame: 96 weeks ]
    Dynamics of viral load (HIV RNA) in blood plasma
  • 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
  • The frequency of virological failures [ Time Frame: 96 weks ]
    The frequency of virological failures, including incomplete suppression or the resumption of viral load
  • Absolute CD8+ lymphocytes count [ Time Frame: 96 weeks ]
    Change in the absolute CD8+ lymphocytes count
  • 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

Estimated Enrollment: 2000
Study Start Date: March 15, 2018
Estimated Study Completion Date: December 31, 2022
Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03706950

Contacts

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

Locations

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

Study Director: Elena Yakubova, PhD Viriom
More Information

More Information


Responsible Party: Viriom  
ClinicalTrials.gov Identifier: NCT03706950   History of Changes  
Other Study ID Numbers: HIV-VM1500-06  
Study First Received: October 11, 2018  
Last Updated: October 15, 2018  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Viriom:

HIV-1

ClinicalTrials.gov processed this data on October 15, 2019
This information is provided by ClinicalTrials.gov.