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
This open-label, multicenter, multi-cohort study is to assess the safety, tolerability, and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) in treatment-naive and treatment-experienced HIV-positive, adult participants with mild to moderate renal impairment. The primary objective of this study is to evaluate the effect of E/C/F/TAF STR on renal parameters at Week 24. The proportion of subjects achieving virologic response of HIV-1 RNA < 50 copies/mL will also be assessed. At sites able to conduct the appropriate testing, approximately 30 participants will be enrolled into an intensive pharmacokinetic/pharmacodynamic (PK/PD) substudy to evaluate the PK/PD parameters of the individual components of E/C/F/TAF as well as tenofovir diphosphate (TFV-DP).
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : E/C/F/TAF
Phase: Phase 3
Ages Eligible For Study:
Cohort 1 (Treatment-experienced Switch) - Must not have a history of known resistance to elvitegravir (EVG), tenofovir disoproxil fumarate (TDF), or emtricitabine (FTC) - Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels (according to the local assay being used) in the 6 months preceding the screening visit and have HIV-1 RNA < 50 copies/mL at screening - Estimated GFR 30-69 mL/min according to the Cockcroft-Gault formula for creatinine clearance, using actual weight - May be currently enrolled in Gilead studies GS-US-236-0102, GS-US-236-0103, and GS-US-216-0114, but will be eligible to enroll only after the Week 144 visit is complete, or currently receiving Stribild« (STB) or atazanavir (ATV)/cobicistat (COBI) + Truvada (TVD) in Gilead studies GS-US-236-0104 or GS-US-216-0105, but will be eligible to enroll only after the Week 48 visit is complete. Cohort 2 (Treatment-na´ve) - Plasma HIV-1 RNA levels ? 1,000 copies/mL at screening - Screening genotype report provided by Gilead Sciences must show sensitivity to EVG, FTC, and TDF - No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for PrEP (pre-exposure prophylaxis), or PEP (post-exposure prophylaxis), up to 6 months prior to screening - Estimated GFR 30-69 mL/min according to the Cockcroft Gault formula for creatinine clearance, using actual weight All Cohorts: All subjects must meet all of the following inclusion criteria to be eligible for participation in this study: - The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - CD4+ count of ? 50 cells/?L - Stable renal function: serum creatinine measurements to be taken at least once (within three months of screening). - Cause of underlying chronic kidney disease (eg hypertension, diabetes) stable, without change in medical management, for 3 months prior to baseline - Normal electrocardiogram (ECG) - Hepatic transaminases (AST and ALT) ? 5 x upper limit of normal (ULN) - Total bilirubin ? 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function - Serum amylase ? 5 x ULN - Females of childbearing potential must agree to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence) from screening throughout the duration of study treatment and for 30 days following the last dose of study drug - Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing - Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of investigational medicinal product. A highly effective method of contraception is defined as two separate forms of contraception, one of which must be an effective barrier method, or male subjects must be non-heterosexually active, or practice sexual abstinence - Age ? 18 years