HIV-1-infection
Conditions
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.
Interventions
DRUGB/F/TAF
B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily
DRUGAtripla
Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily
DRUGB/F/TAF Placebo
Tablet taken orally once daily
DRUGAtripla Placebo
Tablet taken orally once daily
Sponsors
Gilead Sciences
University of British Columbia
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine Albumin/Creatinine Ratio (UACR) | Baseline and week 48 | change in urine albumin/creatinine ratio (UACR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Urine Protein/Creatinine Ratio (UPCR) | Baseline and week 48 | change in urine protein/creatinine ratio (UPCR) |
| 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 |
| HIV-1 RNA | Week 48 | Number of participants with HIV-1 RNA \< 50 copies/mL |
| CD4 Lymphocyte Counts | Baseline and week 48 | change in CD4 lymphocyte counts |
| Serum Lipids | Baseline and week 48 | change in serum lipids |
| Adverse Events | Baseline, week 4, week 12, week 24, week 36, and week 48 | number of adverse events |
| Bone Mineral Density (BMD) at the Spine | Baseline and week 48 | change in bone mineral density (BMD) at the spine |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
B/F/TAF: B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily
Atripla Placebo: Tablet taken orally once daily | 14 |
| 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
Atripla: Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily
B/F/TAF Placebo: Tablet taken orally once daily | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Atripla | Total | B/F/TAF |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 26 Participants | 13 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 14 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Lebanese | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 7 Participants | 11 Participants | 4 Participants |
| Region of Enrollment Canada | 14 Participants | 28 Participants | 14 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 11 Participants | 22 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 8 / 14 | 5 / 14 |
| serious Total, serious adverse events | 0 / 14 | 1 / 14 |
Outcome results
Primary
Urine Albumin/Creatinine Ratio (UACR)
change in urine albumin/creatinine ratio (UACR)
Time frame: Baseline and week 48
Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
Secondary
Adverse Events
number of adverse events
Time frame: Baseline, week 4, week 12, week 24, week 36, and week 48
Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
Secondary
Bone Mineral Density (BMD) at the Hip
change in bone mineral density (BMD) at the hip
Time frame: Baseline and week 48
Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
Secondary
Bone Mineral Density (BMD) at the Spine
change in bone mineral density (BMD) at the spine
Time frame: Baseline and week 48
Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
Secondary
CD4 Lymphocyte Counts
change in CD4 lymphocyte counts
Time frame: Baseline and week 48
Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
Secondary
Efavirenz (EFV) Symptom Scores
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.
Time frame: Baseline and week 4
Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
Secondary
Estimated Glomerular Filtration Rate (eGFR)
change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline and week 48
Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
Secondary
HIV-1 RNA
Number of participants with HIV-1 RNA \< 50 copies/mL
Time frame: Week 48
Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
Secondary
Serum Lipids
change in serum lipids
Time frame: Baseline and week 48
Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
Secondary
Urine Protein/Creatinine Ratio (UPCR)
change in urine protein/creatinine ratio (UPCR)
Time frame: Baseline and week 48
Population: Data was not collected. Study terminated due to difficulties in enrolling participants.