A significant milestone has been reached in the fight against paediatric HIV with the enrolment of the first participants in the UNIVERSAL 1 trial. This achievement is a testament to the tremendous effort and dedication of the site staff in Uganda and Zimbabwe. ...
Laurus Labs has submitted an application to the US Food and Drug Administration (FDA) for the tentative approval of paediatric Darunavir/ritonavir (pDRV/r (120/20 mg)). UNIVERSAL is the first product development project from the World Health Organisation's (WHO) GAP-F...
The UNIVERSAL project is proud to announce the submission of a pharmacokinetic modelling and simulation analysis to the US Food and Drug Administration (FDA). This submission aims to support the new dosing of Darunavir/Ritonavir (DRV/r) 120/20mg, combined in one...
In recent years, advancements in medical research have paved the way for an array of treatment options for children living with HIV. The efforts of scientists and researchers globally, have led to continuous refinement and improvement of existing regimens. Dr. Vivian...
- Partnership Aims to Accelerate the Development of Dispersible Pediatric HIV Medicines - FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) is pleased to announce two public-private partnerships. The first will accelerate the...
The inaugural Clinical Trial Management training program took place online on Wednesday, 14 June 2023, after 428 participants registered. The session was well attended by up to 168 clinical trial staff representing 30 countries. The training course is being...
The UNIVERSAL General Assembly meeting was held from 22 to 24 May 2023, in Harare, Zimbabwe. The UNIVERSAL project aims to develop two antiretroviral fixed-dose combinations for infants and children newly diagnosed with HIV. These formulations will also benefit...
Welcome to the “Get to know the UNIVERSAL project” series! Here we will introduce you to the various work packages and facets that make up the UNIVERSAL project. The UNIVERSAL-Relative Bioavailability (RBA) sub-study will inform the UNIVERSAL 1 trial which aims to...
Welcome to the of the “Get to know the UNIVERSAL project” series! Here we will introduce you to the various work packages and facets that make up the UNIVERSAL project. Pharmacokinetic study of new DTC, FTC, TAF dose ratio (Work package 3) Within the...
Welcome to the “Get to know the UNIVERSAL project” series! Here we will introduce you to the various work packages and facets that make up the UNIVERSAL project. Assessing the long-term safety of ART drugs (Work package 5) Prompt treatment of children living...