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

University of Alberta

Status and phase: Terminated; Phase 4

Conditions: HIV-1-infection

Treatments: Drug: Atripla; Drug: B/F/TAF Placebo; Drug: B/F/TAF; Drug: Atripla Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03532425

BFTAF vs Atripla

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

B/F/TAF

Experimental group

Description:

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

Treatment:

Drug: B/F/TAF

Drug: Atripla Placebo

Atripla

Active Comparator group

Description:

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

Treatment:

Drug: B/F/TAF Placebo

Drug: Atripla