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)

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.

Study Overview

• Status: Unknown
• Conditions: HIV-1-infection
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AEs and SAEs	Incidence of adverse events (AEs) and serious adverse events (SAEs)	96 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral load	Dynamics of viral load (HIV RNA) in blood plasma	96 weeks
Proportion of patients with undetectable viral load on visits, starting from Week 24	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	24 weeks
The frequency of virological failures	The frequency of virological failures, including incomplete suppression or the resumption of viral load	96 weks
Absolute CD8+ lymphocytes count	Change in the absolute CD8+ lymphocytes count	96 weeks
The percent of patients who developed HIV-1 resistance to Elpida®	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	96 weeks

Collaborators and Investigators

• Sponsor: Viriom
• Investigators: Study Director: Elena Yakubova, PhD, Viriom

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: HIV-1
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Elsulfavirine
• Other Study ID Numbers: HIV-VM1500-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No