Observational Multicentre Ibalizumab Study of Efficacy (PROMISE)
Research type
Research Study
Full title
A Prospective and Retrospective, Observational Multicentre Ibalizumab Study of Efficacy (PROMISE)
IRAS ID
298353
Contact name
Shaliha Naufal
Contact email
Sponsor organisation
Theratechnologies Europe Limited
Clinicaltrials.gov Identifier
39579, EU PAS register number
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
This is a multi-centre, multi-country retrospective and prospective observational cohort study that will evaluate the long-term efficacy of the drug ibalizumab in combination with other antiretrovirals. This will be done by looking at patient’s routine healthcare data to see how effective and long-lasting ibalizumab is when used in combination with other anti-retroviral used to treat multi-drug resistance Human Immunodeficiency Virus (HIV)-1 infection. This study is an observational study and therefore, no study specific medication will be administered, no additional medical procedures will be performed and there will be no additional visits as part of this study. Your treatments and routine visits will take place as part of your routine healthcare and data that is normally recorded as part of your routine treatment and healthcare will be analysed. The study will consist of approximately 700 participants in cohort 1 and up to approximately 230 participants in cohort 2. Participants in cohort 1 are those who have not yet or will not receive treatment with ibalizumab. Participants in cohort 2 are those who will or have already received treatment with ibalizumab. If you participate in cohort 1 and are later treated with ibalizumab, you will be able to take part in cohort 2. The clinical outcomes of patients receiving ibalizumab treatment vs. matched patients not receiving ibalizumab will be compared. The study will be conducted at up to 50 sites across Europe. The duration of this study will be approximately 5 years.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0138
Date of REC Opinion
27 May 2021
REC opinion
Favourable Opinion