0112 -Phase 3 open-label study in HIV-1 patients with renal impairment
Research type
Research Study
Full title
A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients with Mild to Moderate Renal Impairment
IRAS ID
128690
Contact name
Anton Pozniak
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2013-000516-25
Clinicaltrials.gov Identifier
Research summary
Medications that target the HIV virus have led to dramatic improvements in survival for infected patients. Whilst HIV treatment has improved greatly over recent years, complications including kidney disease are posing greater risks to patients’ health. HIV patients are at risk of acute and chronic kidney disease from a wide variety of causes, therefore a medication regimen that is simpler to take, with less negative effects on the kidneys, is needed for patients with chronic kidney disease and HIV-infection.
This is a study in HIV-positive patients with mild to moderate kidney impairment of an experimental tablet that combines four drugs for complete treatment of HIV infection: Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide (E/C/F/TAF). Patients taking the experimental tablet will know what they are taking (‘open label’ design). E/C/F/TAF has previously been tested in people with HIV infection, but not in people with HIV infection and kidney disease. The purpose of this study is to evaluate the effect of the E/C/F/TAF in HIV-1 positive patients with mild to moderate kidney impairment after 24 weeks.
Participants will be assigned to one of two treatment groups, and will receive one tablet daily with food:
Group 1: HIV-1 positive adults who have previously received treatment (up to 100 participants)
Group 2: HIV-1 positive adults who have not been treated previously (up to 50 participants)Study duration is up to 96 weeks of treatment with at least 17 scheduled visits. Participants will then complete a 30 day follow up visit. Procedures involved (to monitor drug safety) include physical exams, vital signs, blood tests, ECGs, DEXA scans, renal ultrasounds, HIV related assessments and patient diaries.
This study is sponsored by Gilead Sciences, Inc. Approximately 150 participants from 150 sites worldwide will participate. Approximately 4 participants will be recruited in the UK.
REC name
London - Harrow Research Ethics Committee
REC reference
13/LO/0821
Date of REC Opinion
28 Aug 2013
REC opinion
Further Information Favourable Opinion