GSK205858 Study

GSK205858 Study: Continued Access to Etravirine in Treatment-Experienced HIV-1 Infected Individuals. The GSK205858 Study is a non-randomized, open-label, multi-center rollover study designed to provide continued access to investigational products (IP) for treatment-experienced HIV-1 infected pediatric participants who previously took part in parent studies P1093 or P2019.

Rationale

The aim of the study is to provide continuous access to Etravirine (ETR) for individuals who have completed a clinical study with ETR sponsored by or in collaboration with Janssen Research & Development.

The primary objective is to continue the provision of ETR for subjects who previously received ETR in a clinical trial sponsored by or in collaboration with Janssen Research & Development, and who continue to benefit from the use of ETR, in countries where ETR is not commercially available for the subject’s indication, is not reimbursed, and cannot be accessed through another source (e.g. access program or government program), or where the subject is not eligible for ongoing trials/programs with ETR.

Primary Objective

To continue the provision of ETR for eligible participants who have previously received and benefited from ETR during a clinical trial, in settings where the product is not yet commercially available, not reimbursed, or inaccessible through other channels such as government programs or access schemes.

Secondary Objectives

To monitor:

• The incidence and severity of serious adverse events (SAEs)

• Any clinical or laboratory adverse events that lead to the discontinuation of the investigational product (Tivicay or ABC/DTG/3TC)

Study Sites

• Wits RHI Shandukani Research Centre (SRC), South Africa

Investigators

• Prof Lee Fairlie, Principal Investigator
• Dr Elizea Horne, Sub-Investigator
• Dr Faeezah Patel, Sub-Investigator
• Dr Mrinmayee Dhar, Sub-Investigator

Latest Update

March 2024

For more about GSK205858 Study please email rhicomms@wrhi.ac.za