Trial Outcomes & Findings for Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) After Renal Transplant (NCT NCT04530630)

NCT ID: NCT04530630

Last Updated: 2025-08-12

Results Overview

HIV viral loads will be obtained from lab reports.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Up to week 48 (End of Study)
• Results posted on: 2025-08-12

Participant Flow

Participant milestones

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Overall Study Physician Decision	1

Baseline Characteristics

Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) After Renal Transplant

Baseline characteristics by cohort

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=20 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to week 48 (End of Study)

Population: One subject was excluded from data analysis due to early study withdrawal.

HIV viral loads will be obtained from lab reports.

Outcome measures

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=19 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml	19 Participants

PRIMARY outcome

Timeframe: Up to week 48 (End of study)

Population: One subject was excluded from data analysis due to early withdrawal.

Outcome measures

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=20 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Safety (Tolerability) as Measured by the Number of Subjects Who Had a Serious Adverse Event (SAE)	1 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: One subject was excluded from data analysis due to early withdrawal.

Fmol/punch refers to the concentration of a substance, measured in femtomoles per a specific size of a dried blood spot (DBS) punch.

Outcome measures

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=19 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Intracellular TAF Levels as Measured by Dried Blood Spot Tenofovir-diphosphate (TFV-DP)	1.71 Femtomole (fmol)/punch of DBS Interval 1.29 to 2.25
Intracellular TAF Levels as Measured by Dried Blood Spot Emtricitabine triphosphate (FTC-TP)	1.18 Femtomole (fmol)/punch of DBS Interval 0.88 to 1.59

PRIMARY outcome

Timeframe: 12 weeks

Population: One subject was excluded from data analysis due to early withdrawal.

pmol/10^6 cells refers to the amount of a particular substance (in picomoles) per one million cells

Outcome measures

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=19 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs) TFV-DP	2.87 pmol/10^6 cells Interval 2.0 to 4.12
Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs) FTC-TP	2.76 pmol/10^6 cells Interval 1.85 to 4.12

PRIMARY outcome

Timeframe: 24 weeks, 48 weeks (End of study)

Population: One subject was excluded from data analysis due to early withdrawal.

Outcome measures

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=19 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Renal Function as Measured by Blood Urea Nitrogen (BUN) week 24	25.21 mg/dL Standard Deviation 9.06
Renal Function as Measured by Blood Urea Nitrogen (BUN) week 48	23.47 mg/dL Standard Deviation 9.62

PRIMARY outcome

Timeframe: 24 weeks, 48 weeks (End of study)

Population: One subject was excluded from data analysis due to early withdrawal.

Outcome measures

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=19 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Renal Function as Measured by Creatinine week 24	1.61 mg/dL Standard Deviation 0.52
Renal Function as Measured by Creatinine week 48	1.57 mg/dL Standard Deviation 0.52

PRIMARY outcome

Timeframe: 24 weeks, 48 weeks (End of study)

Population: One subject was excluded from data analysis due to early withdrawal.

Outcome measures

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=19 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Renal Function as Measured by Creatinine Clearance week 48	60.68 mL/min Standard Deviation 15.78
Renal Function as Measured by Creatinine Clearance Week 24	58.10 mL/min Standard Deviation 15.92

PRIMARY outcome

Timeframe: 24 weeks, 48 weeks (End of study)

Population: One subject was excluded from data analysis due to early withdrawal.

Outcome measures

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=19 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR) week 24	48.32 mL/min/1.73m^2 Standard Deviation 13.98
Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR) week 48	49.21 mL/min/1.73m^2 Standard Deviation 14.84

PRIMARY outcome

Timeframe: 12 weeks, 24 weeks, 48 weeks (End of study)

Population: One subject was excluded from data analysis due to early withdrawal.

Outcome measures

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=19 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Tacrolimus Levels week 12	6.37 ng/mL Standard Deviation 1.78
Tacrolimus Levels week 24	7.97 ng/mL Standard Deviation 3.29
Tacrolimus Levels week 48	6.64 ng/mL Standard Deviation 2.60

SECONDARY outcome

Timeframe: Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study)

Population: 1 participant was excluded from data analysis due to early withdrawal.

Number of CD4+ T lymphocyte counts will be obtained from lab reports

Outcome measures

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=19 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant Baseline	256.5263 cells/µL Interval 19.0 to 680.0
Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant Week 4	305.8333 cells/µL Interval 24.0 to 1033.0
Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant Week 12	342.2105 cells/µL Interval 35.0 to 920.0
Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant Week 24	374.8947 cells/µL Interval 38.0 to 887.0
Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant Week 36	404.6667 cells/µL Interval 103.0 to 958.0
Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant Week 48 (End of Study)	382.4211 cells/µL Interval 129.0 to 1174.0

SECONDARY outcome

Timeframe: Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study)

Population: 1 participant was excluded from data analysis due to early withdrawal.

CD4+ T lymphocyte percentages will be obtained from lab reports

Outcome measures

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=19 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant Baseline	22.6842 Percentage of CD4+ lymphocytes Interval 6.0 to 51.0
Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant Week 4	25.667 Percentage of CD4+ lymphocytes Interval 8.0 to 54.0
Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant Week 12	25.7368 Percentage of CD4+ lymphocytes Interval 8.0 to 53.0
Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant Week 24	27.0526 Percentage of CD4+ lymphocytes Interval 9.0 to 50.0
Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant Week 36	28.1111 Percentage of CD4+ lymphocytes Interval 10.0 to 56.0
Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant Week 48 (End of Study)	26.1579 Percentage of CD4+ lymphocytes Interval 10.0 to 54.0

SECONDARY outcome

Timeframe: up to 48 weeks (End of study)

Population: 1 participant was excluded from data analysis due to early withdrawal.

Data for kidney graft rejection will be extracted from biopsy confirmed rejections.

Outcome measures

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=19 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant	0 Participants

SECONDARY outcome

Timeframe: Week 24, Week 48 (End of study)

Population: One subject was excluded from data analysis due to early withdrawal.

Satisfaction will be measured by the self-reporting health-related quality of life questionnaire ranging from 0 to 6 with higher scores indicating greater satisfaction with Biktarvy.

Outcome measures

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=19 Participants Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Participant Satisfaction With Reduced Pill Burden and Adverse Events (Tolerability) Measured by the Health-related Quality of Life Questionnaire Week 24	5.85 score on a scale Interval 0.0 to 6.0
Participant Satisfaction With Reduced Pill Burden and Adverse Events (Tolerability) Measured by the Health-related Quality of Life Questionnaire Week 48	5.89 score on a scale Interval 0.0 to 6.0

Adverse Events

Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=20 participants at risk Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Immune system disorders Anaphylaxis	5.0% 1/20 • Up to week 48 (End of study)

Other adverse events

Measure	Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) n=20 participants at risk Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Gastrointestinal disorders Loose Stool/ Diarrhea	25.0% 5/20 • Up to week 48 (End of study)

Additional Information

Catherine Small, MD

Weill Cornell Medicine

Phone: 212-746-9803

Email: cbs9003@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place