Clinical trial NCT03532425: B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV-1-infection
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
name: University of British Columbia
First posted: 2018-05-22
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Urine Albumin/Creatinine Ratio (UACR)
timeFrame: Baseline and week 48
Secondary outcomes:
measure: HIV-1 RNA
timeFrame: Week 48
measure: Efavirenz (EFV) Symptom Scores
timeFrame: Baseline and week 4
measure: Urine Protein/Creatinine Ratio (UPCR)
timeFrame: Baseline and week 48
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline and week 48
measure: Bone Mineral Density (BMD) at the Hip
timeFrame: Baseline and week 48
measure: Bone Mineral Density (BMD) at the Spine
timeFrame: Baseline and week 48
measure: CD4 Lymphocyte Counts
timeFrame: Baseline and week 48
measure: Serum Lipids
timeFrame: Baseline and week 48
measure: Adverse Events
timeFrame: Baseline, week 4, week 12, week 24, week 36, and week 48
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Stephen D Shafran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31.
citation: Sax PE, Pozniak A, Montes ML, Koenig E, DeJesus E, Stellbrink HJ, Antinori A, Workowski K, Slim J, Reynes J, Garner W, Custodio J, White K, SenGupta D, Cheng A, Quirk E. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2073-2082. doi: 10.1016/S0140-6736(17)32340-1. Epub 2017 Aug 31.