- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03727152
Switching From Protease Inhibitor/Ritonavir to Generic Single Tablet Regimen of Tenofovir Alafenamide/Emtricitibine/Dolutegravir
Maintenance of Switching From Protease Inhibitor/Ritonavir to Generic Single Tablet Regimen of Tenofovir Alafenamide/Emtricitibine/Dolutegravir in Virologically Suppressed HIV-infected Adults
Study Overview
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Bangkok, Thailand, 10330
- HIV-NAT, Thai Red Cross AIDS Research Centre
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Bangkok, Thailand, 10330
- Police General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Documented HIV-1 infection
- Aged ≥18 years old
Female participant may be eligible to participate if she:
is of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea or >=54 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or, is of child-bearing potential, with a negative pregnancy test at both Screening and week 0 and agrees to use one of the protocol-defined methods of contraception to avoid pregnancy.
- On current ART for at least 6 months prior to study entry
- Current ART includes boosted protease inhibitors
- No more than one HIV-1 plasma RNA >50 copies/mL and <200 copies/L (only one 'blip') in the past 6 months with a subsequent HIV-1 plasma RNA <50 copies/mL
- HIV-1 plasma RNA <50 copies/mL at screening visit
- No prior or current exposure to integrase strand transfer inhibitor (INSTI)
- Have signed the informed consent form
Exclusion Criteria:
- Breastfeeding female
- Pregnancy or positive UPT at screening
- Calculated creatinine clearance as estimated by Cockcroft-Gault equation (CrCl) <60 mL/min,
- Alanine aminotransferase (ALT) >2.5 x ULN,
- Concomitant use of any of the following medications:
(1) aluminum and magnesium-containing antacids, proton-pump inhibitors (2) anticonvulsants: carbamazepine, oxcarbamazepine, phenobarbital, phenytoin (3) antimycobacterials: rifabutin, rifampin, rifapentine (4) St. John's wort
6. Alcohol or drug abuse that, in the opinion of the investigator, would interfere with completion of study procedures
7. Any serious illness that, in the opinion of the investigator, would interfere with completion of study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: generic single tablet regimen of tenofovir alafenamide/e
HIV infected adults currently on protease inhibitor/ritonavir will switch to use generic single tablet regimen of tenofovir alafenamide/emtricitibine/dolutegravir to see if the single tablet can continue to suppress viral replication and be used as a maintenance regimen
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HIV-infected adults who are virologically suppressed and on protease inhibitor/ritonavir are switched to generic single tablet regimen of tenofovir alafenamide/emtricitibine/dolutegravir
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of subjects with undetectable viral load
Time Frame: 48 weeks
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Proportion of participants with plasma HIV-1 RNA <50 copies/mL using Snapshot algorithm at week 48
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48 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants without tolerability failure
Time Frame: weeks 24 and weeks 48
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Proportion of participants without tolerability failure
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weeks 24 and weeks 48
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Cmax of DTG
Time Frame: weeks 24 and weeks 48
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maximum plasma concentration (Cmax) of DTG 50 mg
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weeks 24 and weeks 48
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Tmax of DTG
Time Frame: weeks 24 and weeks 48
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time to reach maximal concentration (Tmax) of DTG 50 mg
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weeks 24 and weeks 48
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AUC of DTG
Time Frame: weeks 24 and weeks 48
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area under the curve of a plasma concentration versus time profile (AUC) of DTG 50 mg
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weeks 24 and weeks 48
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T1/2 of DTG
Time Frame: weeks 24 and weeks 48
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elimination half life (T1/2) of DTG 50 mg
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weeks 24 and weeks 48
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Ke of DTG
Time Frame: weeks 24 and weeks 48
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elimination rate constant (Ke) of DTG 50 mg
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weeks 24 and weeks 48
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CL of DTG
Time Frame: weeks 24 and weeks 48
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total plasma clearance (CL) of DTG 50 mg
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weeks 24 and weeks 48
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Anxiety at baseline will be compared to level of anxiety at weeks 24 and weeks 48.
Time Frame: 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).
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weeks 24 and weeks 48
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Depression at baseline will be compared to depression level at weeks 24 and weeks 48.
Time Frame: weeks 24 and weeks 48
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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).
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weeks 24 and weeks 48
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Changes from baseline in fasting lipid profiles
Time Frame: weeks 24 and weeks 48
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Changes from baseline in fasting lipid profiles (HDL, LDL, cholesterol, TG)
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weeks 24 and weeks 48
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Changes from baseline in insulin
Time Frame: weeks 24 and weeks 48
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Changes from baseline in insulin
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weeks 24 and weeks 48
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Changes from baseline in fasting blood glucose levels
Time Frame: weeks 24 and weeks 48
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Changes from baseline in fasting blood glucose levels
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weeks 24 and weeks 48
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Changes from baseline in renal parameters (creatinine, eGFR)
Time Frame: weeks 24 and weeks 48
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Changes from baseline in renal parameters (creatinine, eGFR)
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weeks 24 and weeks 48
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Changes from baseline in transient elastography results
Time Frame: weeks 24 and weeks 48
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Changes from baseline in transient elastography results
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weeks 24 and weeks 48
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sivaporn Gatechompol, MD, The HIV Netherlands Australia Thailand Research Collaboration
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HIV-NAT 256
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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