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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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HIV-1-infection

Intervention / Treatment
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* Drug: Elpida® + 2 NRTIs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A signed patient information sheet and a form of informed consent to participate in the study. Men and women aged 18 and over. Document supported HIV-1 infection. 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: Current participation in the clinical trial. Significant alcohol and/(or) drug dependence, which, according to the researcher, can prevent collection of data. Increase of AST/ALT levels by more than 2.5 times higher than the upper limit of the reference range at Week 0 visit. Replication stage of chronic hepatitis C (presence of HCV RNA), requiring therapy. Use of Elpida® in violation of indications officially approved by the Ministry of Health of the Russian Federation on the package leaflet. Significant secondary diseases requiring treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elpida® + 2 NRTIs<br>Elpida® 20mg qd in the first line of therapy for HIV-1 infected patients with a background standard ART. | Drug: Elpida® + 2 NRTIs<br>* Elpida® 20mg qd orally + 2 NRTIs standard prescribed ART therapy<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1