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

HIV-1-infection Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03706950
• Other study ID #: HIV-VM1500-06
• Status: Recruiting
• Start date: March 15, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2018
• Source: Viriom
• Contact: Elena Yakubova, PhD
• Phone: +7 (495) 995-49-44
• Email: ey[@]chemrar.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Drug:
• Elpida® + 2 NRTIs
Elpida® 20mg qd orally + 2 NRTIs standard prescribed ART therapy

Locations

Country	Name	City	State
Russian Federation	Regional AIDS Prevention and Control Center	Astrakhan
Russian Federation	Altai Regional Center for the Prevention and Control of AIDS and Infectious Diseases	Barnaul
Russian Federation	Regional Center for the Prevention and Control of AIDS and Infectious Diseases	Chelyabinsk
Russian Federation	Center for AIDS Prevention and Control	Gorno-Altaisk
Russian Federation	Center for the Prevention and Control of AIDS and Infectious Diseases	Khabarovsk
Russian Federation	Clinical Center for AIDS Prevention and Control	Krasnodar
Russian Federation	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
Russian Federation	State Regional Clinical Hospital "City Infectious Clinical Hospital No. 1"	Novosibirsk
Russian Federation	Center for AIDS Prevention and Control	Rostov-on-Don
Russian Federation	St. Petersburg State Budgetary Healthcare Institution "Center for the Prevention and Control of AIDS and Infectious Diseases"	Saint Petersburg
Russian Federation	State Public Health Institution of the Leningrad Region "Center for the Prevention and Control of AIDS and Infectious Diseases"	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Viriom

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AEs and SAEs	Incidence of adverse events (AEs) and serious adverse events (SAEs)	96 weeks
Secondary	Viral load	Dynamics of viral load (HIV RNA) in blood plasma	96 weeks
Secondary	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
Secondary	The frequency of virological failures	The frequency of virological failures, including incomplete suppression or the resumption of viral load	96 weks
Secondary	Absolute CD8+ lymphocytes count	Change in the absolute CD8+ lymphocytes count	96 weeks
Secondary	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