ART First-line Treatment Durability in Russia

Retrospective Evaluation of Treatment Durability Among Treatment-naive HIV-infected Individuals Initiated First-line ART in Russia

This study is a non-interventional retrospective study. Data from patients who signed informed consent form will be collected through retrospective chart or medical records review. Patients have been receiving treatment and diagnostic procedures according to daily clinical practice conducted by his/her physician. There are no procedures that are required as part of this study.

The study is to be conducted in 6 investigational sites across Russia with up to 200 patients recruited per site.

HIV-infected patients with no experience of therapy at time of initiation of ART with NNRTI plus two NRTIs or PI boosted by ritonavir with 2 NRTIs will be enrolled and followed retrospectively for up to 96 weeks with data collection at the approximate time points of baseline (pre-treatment) and at 48 and 96 weeks after start of treatment.

The following ARV drugs are considered according to the standards of care:

• NNRTIs: efavirenz (EFV), nevirapine (NVP), rilpivirine (RPV), ETR (etravirine)
• PIs: LPV (lopinavir), DRV (darunavir), ATV (atazanavir), FPV (fosamprenavir)

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Drug: Antiretroviral/Anti HIV

Detailed Description

All patients must have initiated ART between February 01 and April 30, 2017. A time window for the retrospective visits at baseline, 48 and 96 weeks is envisaged as approximately ± 8 weeks.

Patients will be retrospectively screened and selected according to inclusion and exclusion criteria prior to enrollment in each investigational site starting the day of its initiation. The study sites will maintain a list of all screened patients. All patients eligible according to the inclusion/exclusion criteria and after signing the informed consent form are to be consequently enrolled for their demographic and clinical data collection through retrospective chart or medical records review. The enrollment will continue until the recruitment goal is reached.

Baseline and follow-up data will be extracted through retrospective chart or medical records review, if available at each investigational site. No additional interventional testsor medical procedures such as additional blood samples, X-ray or other technical investigations will be performed as a part of this study. If any data element is not available, it will be reported as missing.

At baseline, demographic and clinical data on age, gender, employment status, marital status, substance abuse, HIV diagnosis duration, route of infection, AIDS stage, viral load, CD4 count, concomitant medication, comorbidities (noted diagnosis by physician) are to be collected through retrospective chart or medical records review.

At 48 and 96 weeks of retrospective follow-up, the investigators will assess through the medical records whether the patient was still on treatment with initiated ART (NNRTI, PI) and evaluate the estimated time on therapy without change of the NNRTI or PI agent within the class or without change of the NNRTI or PI agent to a different class.

• Study Type: Observational
• Enrollment (Actual): 536

Contacts and Locations

Study Locations

• Russian Federation
  • Irkutsk, Russian Federation
    • Irkutsk Regional AIDS Center
  • Moscow, Russian Federation
    • Moscow City AIDS Center of the Moscow Health Department
  • Saint Petersburg, Russian Federation
    • Saint-Petersburg AIDS and Infectious Diseases Center
  • Samara, Russian Federation
    • Samara Region AIDS Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients enrolled must be treatment naive at the time of initiation of ART with NNRTI plus two NRTIs or PI boosted by ritonavir with 2 NRTIs per the usual standard of care of the investigator in AIDS clinics of Russia.

Description

Inclusion Criteria:

• Adult patients (>18 years of age) with definite HIV-1 infection based on positive lab test and judgement of treating physician according to standards of care
• Naive to antiretroviral treatment at the time of initiation
• Viral load of >1000 copies/ml at the time of initiation of ART
• Initiated their first-line ART between February 01 and April 30, 2017
• Patients are included, if the third component of their first line ART was either NNRTI or boosted PI plus NRTIs
• Completed follow-up from baseline for at least 96 weeks
• Signed informed consent

Exclusion Criteria:

• HIV-2 infection

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
48 Weeks Treatment Durability	Percentage of patients remained on initial therapy without change of the NNRTI or PI agent	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
96 Weeks Treatment Durability	Percentage of patients remained on initial therapy without change of the NNRTI or PI agent	96 weeks
Time on Therapy at 48 Weeks	Estimated time on therapy without change of the NNRTI or PI agent at 48 weeks among treatment naive HIV-infected individuals initiated ART (NNRTI, PI)	48 weeks
Time on Therapy at 96 Weeks	Estimated time on therapy without change of the NNRTI or PI agent at 96 weeks among treatment naive HIV-infected individuals initiated ART (NNRTI, PI)	96 weeks

Collaborators and Investigators

• Sponsor: MSD Pharmaceuticals LLC
• Investigators: Study Director: Ekaterina Lukyanova, MD, MSD Pharmaceuticals LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Anti-Retroviral Agents
• Other Study ID Numbers: VEAP 8370

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