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

Viriom

Status: Unknown

Conditions: HIV-1-infection

Treatments: Drug: Elpida® + 2 NRTIs

Study type: Observational

Funder types: Industry

Identifiers

NCT03706950

HIV-VM1500-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,000 participants in 1 patient group

Elpida® + 2 NRTIs

Description:

Elpida® 20mg qd in the first line of therapy for HIV-1 infected patients with a background standard ART.

Treatment:

Drug: Elpida® + 2 NRTIs