Study to Compare BIC/LEN Versus Current Therapy in People With HIV-1
Research type
Research Study
Full title
An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens
IRAS ID
1006253
Contact name
Mauricio Montezuma
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2022-500929-33
Clinicaltrials.gov Identifier
Research summary
This is a clinical research study aimed at individuals that have been diagnosed with HIV-1 on a stable complex treatment regimen. The purpose of this study is to determine how Bictegravir (BIC) plus Lencapavir (LEN) in two different doses affects the HIV-1 infection and compare it with current standard treatment regimens. The study will also determine which of these treatments are the most effective for treating HIV 1 infection. The other purpose of this study is to test if BIC plus LEN at these two different LEN doses are safe and tolerated by people with HIV. We will find out about the safety of these two doses, how well the study drug(s) is tolerated, and how long it stays in the body using physical exams, laboratory tests, ECG, blood analysis, and any symptoms or problems participants might experience during the study.\nThis research is of vital importance as HIV-1 infection is a life-threatening and serious disease of major public health significance with\napproximately 38 million people with HIV (PWH) worldwide and approximately 26 million taking antiretroviral (ARV) treatment.\nThis study consists of two different portions: Phase 2 and Phase 3. The Phase 3 portion of the study will enrol once Week 24 data from the Phase 2 portion is reviewed and the dose for a fixed dose combination (FDC) tablet of BIC/LEN is determined.\nThis research study will be conducted in a multicentre setting across the globe, where about 671 participants will take part, and 125 participants out of 671 will take part in Phase 2 portion of the study at about 100 study sites globally, including in the United Kingdom.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0383
Date of REC Opinion
25 Nov 2022
REC opinion
Further Information Favourable Opinion