Efficacy, Safety & Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03502005|
Recruitment Status : Completed
First Posted : April 18, 2018
Last Update Posted : January 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Drug: bictegravir/emtricitabine/tenofovir alafenamide||Phase 4|
Therapeutic dosage of the tenofovir disoproxil fumarate (TDF) component of ATRIPLA® requires plasma concentrations of the drug that are associated with nephrotoxicity and decreased bone mineral density. Tenofovir alafenamide fumarate (TAF) has a unique metabolism that results in higher intracellular levels of the active phosphorylated moiety tenofovir-diphosphate. Compared with TDF, the therapeutic dosage of TAF reduces tenofovir plasma concentrations by over 90%. This reduction in plasma concentration results in decreased renal and bone risks. TAF has the potential to improve on the efficacy and safety profile of TDF.
Efavirenz, another component of ATRIPLA® is widely associated with neuropsychiatric side-effects, including sleep disturbances, depression, and anxiety. Switching from Efavirenz to an integrase inhibitor is associated with improvements in mood.
Bictegravir (BIC) is a novel, once daily integrase inhibitor. It has been shown to have potent antiviral activity, a favorable pharmacokinetic profile, good tolerability and an improved resistance profile when compared to previous integrase inhibitors. In a phase 2 trial investigating previously untreated people with HIV, bictegravir plus emtricitabine and tenofovir alafenamide (BIKTARVY®) vs dolutegravir, plus emtricitabine and tenofovir alafenamide both showed high efficacy up to 24 weeks and both regimens were well tolerated.
Additionally, switching HAART experienced patients to BIKTARVY® has been shown to be non-inferior to continuation of regimens containing Atazanavir or Darunavir, when they were given with either lamivudine/abacavir or FTC/TDF.
The Investigators plan to evaluate in a real world setting the efficacy, safety and tolerability of switching from the older, established single tablet regimen of ATRIPLA® (EFV/FTC/TDF) to a new single tablet regimen of BIKTARVY® (BIC/FTC/TAF).
Within the limitations of a real-world study, Investigators have attempted to replicate the protocol of Gilead Science's Phase 3 study evaluating a switch to BIC/FTC/TAF from dolutegravir plus either FTC/TAF or FTC/TDF14. This will have the potential benefit of comparing different regimen switches as well as potentially adding robustness to the body of data regarding BIC/FTC/TAF.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective 48 week single cohort study to evaluate the efficacy and safety of switching from ATRIPLA to BIKTARVY® in HIV-1 infected adult subjects who are virologically suppressed (HIV-1 RNA < 50 copies/mL).|
|Masking:||None (Open Label)|
|Official Title:||"Efficacy, Safety, and Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1 Infection."|
|Actual Study Start Date :||March 1, 2018|
|Actual Primary Completion Date :||December 30, 2019|
|Actual Study Completion Date :||December 30, 2019|
initiation of single pill once daily bictegravir/emtricitabine/tenofovir alafenamide from prior efavirenz/emtricitabine/tenofovir DF
Drug: bictegravir/emtricitabine/tenofovir alafenamide
Discontinue ATRIPLA® and initiate BIKTARVY®
Other Name: BIKTARVY® (BIC/FTC/TAF)
- assess proportion of patients who develop increase in HIV-1 RNA viral load of ≥ 50 copies/mL [ Time Frame: 24 weeks ]by week 24
- assess stability of kidney function by serial measuring of serum creatinine mg/dL [ Time Frame: 48 weeks ]weeks 24 and 48
- Assess effect on restoration of immune markers by serial measurement of CD4+ cells [ Time Frame: 48 weeks ]weeks 24 and 48
- assess effect on lipid cardiovascular risk factors by serial measurement of triglycerides and HDL/LDL cholesterol [ Time Frame: 48 weeks ]weeks 24 and 48
- assess proportion of patients who continue to have HIV-1 RNA measured <50 copies/mL [ Time Frame: 48 weeks ]weeks 24 and 48
- Assess patient reported outcomes by two validated patient questionnaires Philadelphia Sleep Quality Index and HIV Symptom Index [ Time Frame: 48 weeks ]by week 48
- assess patient weight variations from baseline [ Time Frame: 48 weeks ]weeks 24 and 48
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502005
|United States, Florida|
|Midland Research Group, Inc|
|Oakland Park, Florida, United States, 33334|
|Principal Investigator:||Noah Lee, DO||Midland Research Group, Inc.|