Switching From Protease Inhibitor/Ritonavir to Generic Single Tablet Regimen of Tenofovir Alafenamide/Emtricitibine/Dolutegravir

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    190
  • sponsor
    The HIV Netherlands Australia Thailand Research Collaboration
Updated on 26 January 2021
hysterectomy
tenofovir
emtricitabine
protease
ritonavir
dolutegravir
integrase inhibitors
HIV Vaccine
hiv-1 infection

Summary

This is a phase III, multicenter, open-label, single-arm study of 190 virologically suppressed HIV-infected adults

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.

Details
Condition HIV, HIV positive, HIV infection, AIDS Vaccines, HIV (Pediatric), HIV Infections, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines
Treatment generic single tablet TAF/FTC/DTG
Clinical Study IdentifierNCT03727152
SponsorThe HIV Netherlands Australia Thailand Research Collaboration
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
\. Alcohol or drug abuse that, in the opinion of the investigator, would
interfere with completion of study procedures
\. Any serious illness that, in the opinion of the investigator, would
interfere with completion of study procedures
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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