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

Phase 4

Terminated

• Conditions: HIV-1-infection
• Interventions: Drug: B/F/TAF; Drug: Atripla; Drug: Atripla Placebo; Drug: B/F/TAF Placebo

• Registration Number: NCT03532425
• Lead Sponsor: University of Alberta

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-22
• Study Start: 2018-10-29
• Primary Completion: 2020-08-03
• Study Completion: 2020-09-03
• Results First Submitted: 2022-09-19
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-21
• Last Update Submitted: 2022-11-21
• Results First Posted: 2022-12-14
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B/F/TAF	Atripla Placebo	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
Atripla	B/F/TAF Placebo	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
B/F/TAF	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
Atripla	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

Primary Outcome Measures

Name	Time	Method
Urine Albumin/Creatinine Ratio (UACR)	Baseline and week 48	change in urine albumin/creatinine ratio (UACR)

Secondary Outcome Measures

Name	Time	Method
Efavirenz (EFV) Symptom Scores	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.
Adverse Events	Baseline, week 4, week 12, week 24, week 36, and week 48	number of adverse events
Urine Protein/Creatinine Ratio (UPCR)	Baseline and week 48	change in urine protein/creatinine ratio (UPCR)
HIV-1 RNA	Week 48	Number of participants with HIV-1 RNA \< 50 copies/mL
Estimated Glomerular Filtration Rate (eGFR)	Baseline and week 48	change in estimated glomerular filtration rate (eGFR)
Bone Mineral Density (BMD) at the Hip	Baseline and week 48	change in bone mineral density (BMD) at the hip
CD4 Lymphocyte Counts	Baseline and week 48	change in CD4 lymphocyte counts
Bone Mineral Density (BMD) at the Spine	Baseline and week 48	change in bone mineral density (BMD) at the spine
Serum Lipids	Baseline and week 48	change in serum lipids

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada