B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults
Condition: HIV-1-infection
Intervention: B/F/TAF; Atripla; B/F/TAF Placebo; Atripla Placebo
Intervention description: B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily; Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily; Tablet taken orally once daily; Tablet taken orally once daily
Intervention MeSH terms: Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

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.
    

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)