A Phase 4 interventional study of bictegravir/emtricitabine/tenofovir alafenamide in Human Immunodeficiency Virus, sponsored by Midland Research Group, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Midland Research Group, Inc. · Phase 4, Interventional, and Treatment
This study evaluates 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), in HIV-1 infected adult subjects who are virologically suppressed (HIV-1 RNA\<50 copies/mL).
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 100 is close to the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Midland Research Group, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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®
Also known as: BIKTARVY® (BIC/FTC/TAF)
assess proportion of patients who develop increase in HIV-1 RNA viral load of ≥ 50 copies/mL
by week 24
Time frame: 24 weeks
assess stability of kidney function by serial measuring of serum creatinine mg/dL
weeks 24 and 48
Time frame: 48 weeks
Assess effect on restoration of immune markers by serial measurement of CD4+ cells
weeks 24 and 48
Time frame: 48 weeks
assess effect on lipid cardiovascular risk factors by serial measurement of triglycerides and HDL/LDL cholesterol
weeks 24 and 48
Time frame: 48 weeks
assess proportion of patients who continue to have HIV-1 RNA measured <50 copies/mL
weeks 24 and 48
Time frame: 48 weeks
Assess patient reported outcomes by two validated patient questionnaires Philadelphia Sleep Quality Index and HIV Symptom Index
by week 48
Time frame: 48 weeks
assess patient weight variations from baseline
weeks 24 and 48
Time frame: 48 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — CROI 2020
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
Midland Research Group, Inc.