Clinical Trials

MainTitle

B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2018 by University of Alberta

Sponsor
University of Alberta

Collaborator
Gilead Sciences
University of British Columbia

Information provided by (Responsible Party)
University of Alberta
ClinicalTrials.gov Identifier
NCT03532425

First received: May 9, 2018
Last updated: January 17, 2019
Last Verified: September 2018
History of Changes
Purpose

Purpose

Atripla (ATP: FTC/TDF/EFV) was the first single pill treatment for HIV and was the most prescribed first-line treatment from approximately 2008 to 2013 for people infected with HIV. However, ATP has not been recommended as a "preferred" treatment for HIV since 2015, due to there now being single pill treatments that work better. There are a lot of people who are still taking ATP and it is working for them. However, it has the potential to cause serious side effects (chronic kidney disease and fractures and serious neurological effects). These side effects are caused by components in ATP (namely the TDF and EFV parts). Also, the efavirenz (EFV) component is not compatible for treatment of Hepatitis C (HCV) - which is often also seen in people who have HIV. For these reasons, there is a need to find a better alternative treatment for these people currently being treated with ATP.

B/F/TAF (bictegravir/FTC/TAF) is an investigational single pill drug treatment drug that contains neither TDF nor EFV. This study is looking at whether changing people to this new drug treatment will continue to suppress their HIV and have fewer side effects.

Condition Intervention Phase
HIV-1-infection

Drug : B/F/TAF
Drug : Atripla
Drug : B/F/TAF Placebo
Drug : Atripla Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate to Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Virologically Suppressed Adults

Further study details as provided by University of Alberta:

Primary Outcome Measures

  • urine albumin/creatinine ratio (UACR) [ Time Frame: baseline and week 48 ]
    change in urine albumin/creatinine ratio (UACR)
Secondary Outcome Measures:
  • HIV-1 RNA [ Time Frame: week 48 ]
    Number of participants with HIV-1 RNA < 50 copies/mL
  • efavirenz (EFV) symptom scores [ Time Frame: baseline and week 4 ]
    change in EFV symptom scores from Pittsburgh Sleep Quality Questionnaire (PSQI) global score. PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The PSQI global score has a possible range of 0-21. Higher scores represent worse sleep quality.
  • urine protein/creatinine ratio (UPCR) [ Time Frame: baseline and week 48 ]
    change in urine protein/creatinine ratio (UPCR)
  • estimated glomerular filtration rate (eGFR) [ Time Frame: baseline and week 48 ]
    change in estimated glomerular filtration rate (eGFR)
  • bone mineral density (BMD) at the hip [ Time Frame: baseline and week 48 ]
    change in bone mineral density (BMD) at the hip
  • bone mineral density (BMD) at the spine [ Time Frame: baseline and week 48 ]
    change in bone mineral density (BMD) at the spine
  • CD4 lymphocyte counts [ Time Frame: baseline and week 48 ]
    change in CD4 lymphocyte counts
  • serum lipids [ Time Frame: baseline and week 48 ]
    change in serum lipids
  • adverse events [ Time Frame: baseline, week 4, week 12, week 24, week 36, and week 48 ]
    number of adverse events

Estimated Enrollment: 200
Study Start Date: October 29, 2018
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: B/F/TAF
B/F/TAF + Atripla Placebo Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks
Drug: B/F/TAF

B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily

Other Name: BIKTARVY®
Drug: Atripla Placebo

Tablet taken orally once daily

Active Comparator: Atripla
Atripla + B/F/TAF Placebo Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks
Drug: Atripla

Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily

Drug: B/F/TAF Placebo

Tablet taken orally once daily

Eligibility

Eligibility

Ages Eligible for Study: 21 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

    1. HIV-1 seropositive
    2. Age > 21 years
    3. Receiving ATP > 2 years as their only ART, with HIV-1 RNA < 50 copies/mL at screening and all HIV-1 RNA tests < 100 copies/mL in the past 18 months
    4. No documented resistance mutations to the components of ATP
    5. Any CD4 count, but no active AIDS-defining opportunistic infections or cancers
    6. HBsAg+ permitted if plasma HBV DNA is unquantifiable and the patient does not have decompensated liver disease


Exclusion Criteria:
    1. Pregnancy, breastfeeding or planned pregnancy in the next 2 years
    2. Documented resistance to the components of ATP
    3. Active AIDS-defining opportunistic infection or cancer
    4. Cancer in past 3 years, except non melanoma skin cancer
    5. Active psychotic disease or active depression that may interfere with study participation according investigator discretion
    6. Any illness with a life expectancy less than 2 years
    7. eGFR < 50 mL/min
    8. Urine protein/creatinine > 40 mg/mmoL
    9. Patients who the investigator feels are unlikely to commit to the study requirements for any reason
    10. Prescription drug therapy for osteoporosis (calcium and/or vitamin D is allowed)

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03532425

Contacts

Contact:   Stephen D Shafran, MD 780-407-6945 sshafran@ualberta.ca

Locations

Canada
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Stephen D Shafran, MD    780-407-6945    sshafran@ualberta.ca

Sponsors and Collaborators

University of Alberta
Gilead Sciences
University of British Columbia

Investigators

Principal Investigator: Stephen D Shafran, MD University of Alberta
More Information

More Information

Additional Information:

Related Info

Responsible Party: University of Alberta  
ClinicalTrials.gov Identifier: NCT03532425   History of Changes  
Other Study ID Numbers: BFTAF vs Atripla  
Study First Received: May 9, 2018  
Last Updated: January 17, 2019  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  
Product Manufactured in and Exported from the U.S.: Yes  

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Efavirenz
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on August 16, 2019
This information is provided by ClinicalTrials.gov.