ART First-line Treatment Durability in Russia

NCT04253119 | Completed Results

• 1 other identifier: VEAP 8370
• Study Type: observational
• Target: 536
• Locations: 1 country
• Sites: 4

Brief Summary

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)

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• 48 Weeks Treatment Durability

  Percentage of patients remained on initial therapy without change of the NNRTI or PI agent

  48 weeks

Secondary Outcomes (3)

• 96 Weeks Treatment Durability

  96 weeks

• Time on Therapy at 48 Weeks

  48 weeks

• Time on Therapy at 96 Weeks

  96 weeks

Interventions

Antiretroviral/Anti HIV DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• HIV-2 infection

Sponsors & Collaborators

• MSD Pharmaceuticals LLC: lead

Study Sites (4)

Irkutsk Regional AIDS Center

Irkutsk, Russia

Location

Moscow City AIDS Center of the Moscow Health Department

Moscow, Russia

Location

Saint-Petersburg AIDS and Infectious Diseases Center

Saint Petersburg, Russia

Location

Samara Region AIDS Center

Samara, Russia

Location

Results Point of Contact

• Title: Vladimir Achikyan, Medical Affairs Manager
• Organization: MSD Pharmaceuticals LLC

vladimir.achikyan@merck.com

79161981264

Study Officials

• Ekaterina Lukyanova, MD

  MSD Pharmaceuticals LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: February 5, 2020
• Study Start: November 26, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (4)