Trial Outcomes & Findings for B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults (NCT NCT03532425)
NCT ID: NCT03532425
Last Updated: 2022-12-14
Results Overview
change in urine albumin/creatinine ratio (UACR)
TERMINATED
PHASE4
28 participants
Baseline and week 48
2022-12-14
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults
Baseline characteristics by cohort
| Measure |
B/F/TAF
n=14 Participants
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
|
Atripla
n=14 Participants
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
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Lebanese
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 48Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
change in urine albumin/creatinine ratio (UACR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
Number of participants with HIV-1 RNA \< 50 copies/mL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and week 4Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and week 48Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
change in urine protein/creatinine ratio (UPCR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and week 48Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
change in estimated glomerular filtration rate (eGFR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and week 48Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
change in bone mineral density (BMD) at the hip
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and week 48Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
change in bone mineral density (BMD) at the spine
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and week 48Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
change in CD4 lymphocyte counts
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and week 48Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
change in serum lipids
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 4, week 12, week 24, week 36, and week 48Population: Data was not collected. Study terminated due to difficulties in enrolling participants.
number of adverse events
Outcome measures
Outcome data not reported
Adverse Events
B/F/TAF
Atripla
Serious adverse events
| Measure |
B/F/TAF
n=14 participants at risk
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
|
Atripla
n=14 participants at risk
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
|
|---|---|---|
|
Hepatobiliary disorders
Klebsiella liver abscess
|
0.00%
0/14 • Throughout study period of 52 weeks.
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
Other adverse events
| Measure |
B/F/TAF
n=14 participants at risk
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
|
Atripla
n=14 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/14 • Throughout study period of 52 weeks.
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back and/or knee pain
|
0.00%
0/14 • Throughout study period of 52 weeks.
|
14.3%
2/14 • Throughout study period of 52 weeks.
|
|
Infections and infestations
Common cold/viral respiratory illness
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/14 • Throughout study period of 52 weeks.
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Throughout study period of 52 weeks.
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
|
Surgical and medical procedures
Hemorrhoidectomy
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
0.00%
0/14 • Throughout study period of 52 weeks.
|
|
Hepatobiliary disorders
Elevated ALT
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
0.00%
0/14 • Throughout study period of 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
0.00%
0/14 • Throughout study period of 52 weeks.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
0.00%
0/14 • Throughout study period of 52 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
14.3%
2/14 • Throughout study period of 52 weeks.
|
0.00%
0/14 • Throughout study period of 52 weeks.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
0.00%
0/14 • Throughout study period of 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
0.00%
0/14 • Throughout study period of 52 weeks.
|
|
Surgical and medical procedures
Total ankle arthroplasty
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
0.00%
0/14 • Throughout study period of 52 weeks.
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.1%
1/14 • Throughout study period of 52 weeks.
|
0.00%
0/14 • Throughout study period of 52 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place