Study of E/C/F/TAF in HIV-1 patients on Chronic Haemodialysis
Research type
Research Study
Full title
A Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis
IRAS ID
189474
Contact name
Kaveh Manavi
Contact email
Sponsor organisation
Gilead Science, Inc.
Eudract number
2015-002713-30
Clinicaltrials.gov Identifier
111,007, IND Number
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
The treatment of HIV1 infection requires prompt treatment after diagnosis to delay disease progression and prolong survival. Regimens are required that optimise long term adherence, tolerability and safety. Adherence to the treatment is important to prevent drug resistance and loss of virologic suppression and is increased by reducing the pill burden and dosing frequency.
It has been shown that once daily, single tablet regimens are associated with higher adherence to treatment, better clinical outcomes including fewer hospitalizations, improved patient satisfaction and excellent virological outcomes.
HIV also remains a serious condition due to comorbidities’. The prevalence of chronic kidney disease and end stage renal disease are expected to rise along with the rise in HIV infections.HIV-1 patients with chronic kidney disease have limited therapeutic options. A singe tablet regimen of potent agents with improved tolerability and long term safety that does not require dose adjustment at eGFR <50 mL/m would be an important therapeutic innovation for this patient group.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of E/C/F/TAF FDC (referred to as ‘study drug’) in virologically suppressed HIV-1 infected patients, who are on chronic haemodialysis because of end stage renal disease.
Approximately 50 participants will take part at approximately 50 sites globally. Participation will last 48 weeks, not including the screening period which may last up to 30 days. Participants will be required to visit the clinic at least 9 times (day 1, weeks 2, 4, 8, 12, 24, 36 and 48 and 30 day follow up). After 48 weeks on treatment, they will stop the study drug and complete a 30-Day Follow-up visit to complete their participation in the study.
This is an open label study and all participants who take part in the study will receive E/C/F/TAF FDC.
Open-label means both the patient and their study doctor will know what study drug they will be taking.
The safety and how well these drugs are tolerated, will be determined by using physical exams, laboratory tests, and any symptoms or problems the participants might experience during the study.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0076
Date of REC Opinion
5 Apr 2016
REC opinion
Further Information Favourable Opinion