Post-marketing study to assess the effectiveness of doravirine-included in highly active antiretroviral therapy (HAART) in HIV-1 infected adult Chinese patients (MK-1439-088)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106122
• EU PAS number:
  EUPAS103993
• Study ID:
  106122
• Official title and acronym:
  Post-marketing study to assess the effectiveness of doravirine-included in highly active antiretroviral therapy (HAART) in HIV-1 infected adult Chinese patients (MK-1439-088)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  Human immunodeficiency virus (HIV) is the etiologic agent of acquired immunodeficiency syndrome (AIDS). ; The HIV infection (mainly HIV-1 infection) epidemic in China has evolved significantly over the past 35 years and it remains a major public health problem. ; Doravirine (DOR, tradename PIFELTRO™) is a nonnucleoside reverse transcriptase inhibitors (NNRTI) that is indicated in combination with other antiretroviral medicinal products for the treatment of adults infected with HIV-1 without resistance to the NNRTI class. ; Doravirine, lamivudine, tenofovir disoproxil fumarate(DOR/3TC/TDF, tradename DELSTRIGO™) is a fixed-dose combination indicated for the treatment of adults infected with HIV-1. PIFELTRO™ and DELSTRIGO™ were approved in China in 2020. ; The study aims to assess the effectiveness of doravirine-included highly active antiretroviral therapy (HAART) in HIV-1 infected adult Chinese participants by a retrospective observational study design using medical chart review.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Study timelines

Date when funding contract was signed

Actual: 18/08/2021

Study start date

Planned: 31/07/2023

Actual: 25/07/2023

Data analysis start date

Planned: 15/11/2024

Actual: 30/09/2024

Date of final study report

Planned: 28/02/2025

Actual: 13/02/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp &amp, Dohme LLC

Study protocol

Initial protocol

MK-1439-088-00-v1-Protocol_final redaction

Updated protocol

MK-1439-088-00-v2-Protocol_final redaction (002)

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable