News
and updatesUNIVERSAL data supports Laurus Labs US FDA submission for approval of novel protease inhibitor
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...
UNIVERSAL submits data to the FDA to support the dosing of a new drug combination to treat HIV in children
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...
UNIVERSAL’s potential impact on the health of children living with HIV, told by Dr Vivian Mumbiro
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...
Gilead Partners with CHAI and Penta to Improve Treatment and Adherence Rates Among Children with HIV in Low and Middle Income Countries
- 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...
Inaugural training session for the Clinical Trial Management course
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...
UNIVERSAL General Assembly Meeting 2023
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...
Get to know the UNIVERSAL project: Relative Bioavailability study (PK sub-study)
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...
Get to know the UNIVERSAL project: Pharmacokinetic study of new DTG FTC TAF dose ratio
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...
Get to know the UNIVERSAL project: Assessing the long-term safety of ART drugs
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...
Meet the winners of the UNIVERSAL Student Research Capacity Building and CIPHER grants
Four early career researchers in the field of paediatric HIV recently received the CIPHER Growing the Leaders of Tomorrow Fellowship and the UNIVERSAL Student Research and Capacity Building grant. As beneficiaries of these awards, these young doctors will receive...
