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

NCT03727152 | Completed Phase 3

• 1 other identifier: HIV-NAT 256
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

HIV

Keywords

generic TAF/E/D; virologically suppressed HIV-infected adults; pharmacokinetics (PK) parameters of DTG; psychiatric symptoms; metabolic syndrome; ASCVD risk; liver fibrosis

Outcome Measures

Primary Outcomes (1)

• number of subjects with undetectable viral load

  Proportion of participants with plasma HIV-1 RNA \<50 copies/mL using Snapshot algorithm at week 48

  48 weeks

Secondary Outcomes (14)

• Proportion of participants without tolerability failure

  weeks 24 and weeks 48

• Cmax of DTG

  weeks 24 and weeks 48

• Tmax of DTG

  weeks 24 and weeks 48

• AUC of DTG

  weeks 24 and weeks 48

• T1/2 of DTG

  weeks 24 and weeks 48

Study Arms (1)

generic single tablet regimen of tenofovir alafenamide/e

OTHER

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

Drug: generic single tablet TAF/FTC/DTG

Interventions

generic single tablet TAF/FTC/DTG 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

generic single tablet regimen of tenofovir alafenamide/e

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• Faculty of Medical Sciences, Radboud University of Medical Center: collaborator
• Department of Pharmaceutical care, Faculty of Pharmacy, Chiang Mai University: collaborator
• Police General Hospital: collaborator

Study Sites (2)

HIV-NAT, Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

Police General Hospital

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Metabolic Syndrome; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sivaporn Gatechompol, MD

  The HIV Netherlands Australia Thailand Research Collaboration

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 1, 2018
• Study Start: May 1, 2019
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

TH (2)