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

NCT ID: NCT03727152

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2023-04-04

Brief Summary

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

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.

Conditions

HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

generic single tablet TAF/FTC/DTG

Intervention Type: DRUG

HIV-infected adults who are virologically suppressed and on protease inhibitor/ritonavir are switched to generic single tablet regimen of tenofovir alafenamide/emtricitibine/dolutegravir

Interventions

generic single tablet TAF/FTC/DTG

HIV-infected adults who are virologically suppressed and on protease inhibitor/ritonavir are switched to generic single tablet regimen of tenofovir alafenamide/emtricitibine/dolutegravir

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Documented HIV-1 infection

2. Aged ≥18 years old

3. 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.

4. On current ART for at least 6 months prior to study entry

5. Current ART includes boosted protease inhibitors

6. 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

7. HIV-1 plasma RNA <50 copies/mL at screening visit

8. No prior or current exposure to integrase strand transfer inhibitor (INSTI)

9. Have signed the informed consent form

Exclusion Criteria

1. Breastfeeding female

2. Pregnancy or positive UPT at screening

3. Calculated creatinine clearance as estimated by Cockcroft-Gault equation (CrCl) <60 mL/min,

4. Alanine aminotransferase (ALT) >2.5 x ULN,

5. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faculty of Medical Sciences, Radboud University of Medical Center

UNKNOWN

Sponsor Role: collaborator

Department of Pharmaceutical care, Faculty of Pharmacy, Chiang Mai University

UNKNOWN

Sponsor Role: collaborator

Police General Hospital

OTHER

Sponsor Role: collaborator

The HIV Netherlands Australia Thailand Research Collaboration

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sivaporn Gatechompol, MD

Role: PRINCIPAL_INVESTIGATOR

The HIV Netherlands Australia Thailand Research Collaboration

Locations

HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, , Thailand

Police General Hospital

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

HIV-NAT 256

Identifier Type: -

Identifier Source: org_study_id