Clinical trial NCT03706950: Post-approval Observational Study of Elpida® in the First Line Therapy for HIV-1 Infected Patients With Background Standard ART
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-1-infection
Keywords: HIV-1
Lead sponsor: Viriom
Sponsor class: INDUSTRY
First posted: 2018-10-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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.

Primary outcomes:
measure: Incidence of AEs and SAEs
timeFrame: 96 weeks
Secondary outcomes:
measure: Viral load
timeFrame: 96 weeks
measure: Proportion of patients with undetectable viral load on visits, starting from Week 24
timeFrame: 24 weeks
measure: The frequency of virological failures
timeFrame: 96 weks
measure: Absolute CD8+ lymphocytes count
timeFrame: 96 weeks
measure: The percent of patients who developed HIV-1 resistance to Elpida®
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Astrakhan
country: Russian Federation
facility: Regional AIDS Prevention and Control Center
city: Barnaul
country: Russian Federation
facility: Altai Regional Center for the Prevention and Control of AIDS and Infectious Diseases
city: Chelyabinsk
country: Russian Federation
facility: Regional Center for the Prevention and Control of AIDS and Infectious Diseases
city: Gorno-Altaisk
country: Russian Federation
facility: Center for AIDS Prevention and Control
city: Khabarovsk
country: Russian Federation
facility: Center for the Prevention and Control of AIDS and Infectious Diseases
city: Krasnodar
country: Russian Federation
facility: Clinical Center for AIDS Prevention and Control
city: Moscow
country: Russian Federation
facility: 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
city: Novosibirsk
country: Russian Federation
facility: State Regional Clinical Hospital "City Infectious Clinical Hospital No. 1"
city: Rostov-on-Don
country: Russian Federation
facility: Center for AIDS Prevention and Control
city: Saint Petersburg
country: Russian Federation
facility: State Public Health Institution of the Leningrad Region "Center for the Prevention and Control of AIDS and Infectious Diseases"
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Healthcare Institution "Center for the Prevention and Control of AIDS and Infectious Diseases"
Study officials:
affiliation: Viriom
name: Elena Yakubova, PhD
role: STUDY_DIRECTOR
References: