This is a phase III, multicenter, open-label, single-arm study of 190 virologically suppressed HIV-infected adults
The fundamental principle of regimen switching is to maintain viral suppression without jeopardizing future treatment options. The reasons to consider regimen switching in the viral suppressed population are to simplify the regimen by reducing the pill burden and dosing frequency, to increase the tolerability, reduce the adverse effects as well as long-term toxicities, to prevent drug-to-drug interactions and to avoid the dietary requirements. Generic TAF/E/D (tenofovir alafenamide 25mg/emtricitabine 200mg/dolutegravir 50 mg), a single-tablet once daily regimen, will be an affordable regimen with the potential characteristics such as reduced pill burden, less drug to drug interaction and toxicities. The generic form (Mylan) is recently received the tentative approval from the U.S. Food and Drug Administration (FDA) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). Whether DTG-containing regimen is a better option than protease inhibitors among resource-limited settings during the decisions for second-line treatment options, is needed to be evaluated. All participants will be switched from their pre-study ART regimen to a single tablet regimen (STR) of TAF/FTC/DTG 25/200/50mg once daily.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
170
HIV-infected adults who are virologically suppressed and on protease inhibitor/ritonavir are switched to generic single tablet regimen of tenofovir alafenamide/emtricitibine/dolutegravir
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, Thailand
Police General Hospital
Bangkok, Thailand
number of subjects with undetectable viral load
Proportion of participants with plasma HIV-1 RNA \<50 copies/mL using Snapshot algorithm at week 48
Time frame: 48 weeks
Proportion of participants without tolerability failure
Proportion of participants without tolerability failure
Time frame: weeks 24 and weeks 48
Cmax of DTG
maximum plasma concentration (Cmax) of DTG 50 mg
Time frame: weeks 24 and weeks 48
Tmax of DTG
time to reach maximal concentration (Tmax) of DTG 50 mg
Time frame: weeks 24 and weeks 48
AUC of DTG
area under the curve of a plasma concentration versus time profile (AUC) of DTG 50 mg
Time frame: weeks 24 and weeks 48
T1/2 of DTG
elimination half life (T1/2) of DTG 50 mg
Time frame: weeks 24 and weeks 48
Ke of DTG
elimination rate constant (Ke) of DTG 50 mg
Time frame: weeks 24 and weeks 48
CL of DTG
total plasma clearance (CL) of DTG 50 mg
Time frame: weeks 24 and weeks 48
Anxiety at baseline will be compared to level of anxiety at weeks 24 and weeks 48.
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Anxiety at baseline will be compared to anxiety level at weeks 24 and weeks 48. Anxiety will be assessed using Hospital Anxiety and Depression Scale (HADS). There are 7 different items that assess the level of anxiety of the participants based on a four-point grading scale specific for each item assessed (i.e., I feel tense or 'wound up'; 0 = not at all; 1 = from time to time, occasionally; 2 = a lot of the time; 3 = most of the time). If the total score is between 0-7, then this is considered to be normal. If the total score is between 8-10, then this is considered borderline abnormal (borderline case). If the total score is between 11-21, then this is considered abnormal (case).
Time frame: weeks 24 and weeks 48
Depression at baseline will be compared to depression level at weeks 24 and weeks 48.
Depression at baseline will be compared to depression level at weeks 24 and weeks 48. Depression will be assessed using Hospital Anxiety and Depression Scale (HADS). There are 7 different items that assess the level of depression of the participants based on a four-point grading scale specific for each item assessed (i.e., I still enjoy the things I used to enjoy; 0 = definitely as much; 1 = not quite so much; 2 = only a little; 3 = hardly at all). If the total score is between 0-7, then this is considered to be normal. If the total score is between 8-10, then this is considered borderline abnormal (borderline case). If the total score is between 11-21, then this is considered abnormal (case).
Time frame: weeks 24 and weeks 48
Changes from baseline in fasting lipid profiles
Changes from baseline in fasting lipid profiles (HDL, LDL, cholesterol, TG)
Time frame: weeks 24 and weeks 48
Changes from baseline in insulin
Changes from baseline in insulin
Time frame: weeks 24 and weeks 48
Changes from baseline in fasting blood glucose levels
Changes from baseline in fasting blood glucose levels
Time frame: weeks 24 and weeks 48
Changes from baseline in renal parameters (creatinine, eGFR)
Changes from baseline in renal parameters (creatinine, eGFR)
Time frame: weeks 24 and weeks 48
Changes from baseline in transient elastography results
Changes from baseline in transient elastography results
Time frame: weeks 24 and weeks 48