Overview

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

Status:
Recruiting

Trial end date:
2021-12-31

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators:

Department of Pharmaceutical care, Faculty of Pharmacy, Chiang Mai University
Faculty of Medical Sciences, Radboud University of Medical Center
Police General Hospital

Treatments:

Dolutegravir
HIV Protease Inhibitors
Protease Inhibitors
Ritonavir
Tenofovir

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