HIV Infections, Renal Transplant Rejection
Conditions
Keywords
HIV Positive, Post Renal Transplant, Bictegravir/Emtricitabine/Tenofovir Alafenamide, Antiretroviral, Biktarvy
Brief summary
This is an open-label study, where participants will be switched from their current HIV medication to the study drug, BIC/F/TAF. Open-label means both the investigator and the participant will know what drug will be given. Participants will be followed for 48 weeks in order to monitor the efficacy, safety and tolerability of BIC/F/TAF. The investigator hypothesizes that BIC/F/TAF will be an important addition to the management of HIV-positive post renal transplant patients, especially since it is a one pill daily dosing regimen, thereby decreasing the pill burden in this population.
Interventions
DRUGBIC/F/TAF 50Mg-200Mg-25Mg Tablet
A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide.
Sponsors
Gilead Sciences
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years old on day of signing informed consent * Positive for human immunodeficiency virus (HIV) * Received a previous renal transplant * Must have controlled HIV infection for at least 3 months prior to enrollment
Exclusion criteria
* Received a kidney from a donor who was HIV positive (unless a false positive) * Currently taking BIC/F/TAF for treatment of HIV * Has allergies to any of the HIV medications in BIC/F/TAF (bictegravir, emtricitabine, or tenofovir alafenamide) * Currently taking dofetilide or rifampin * Is pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tacrolimus Levels | 12 weeks, 24 weeks, 48 weeks (End of study) | — |
| Renal Function as Measured by Blood Urea Nitrogen (BUN) | 24 weeks, 48 weeks (End of study) | — |
| Renal Function as Measured by Creatinine | 24 weeks, 48 weeks (End of study) | — |
| Renal Function as Measured by Creatinine Clearance | 24 weeks, 48 weeks (End of study) | — |
| Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR) | 24 weeks, 48 weeks (End of study) | — |
| Safety (Tolerability) as Measured by the Number of Subjects Who Had a Serious Adverse Event (SAE) | Up to week 48 (End of study) | — |
| Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml | Up to week 48 (End of Study) | HIV viral loads will be obtained from lab reports. |
| Intracellular TAF Levels as Measured by Dried Blood Spot | 12 weeks | Fmol/punch refers to the concentration of a substance, measured in femtomoles per a specific size of a dried blood spot (DBS) punch. |
| Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs) | 12 weeks | pmol/10\^6 cells refers to the amount of a particular substance (in picomoles) per one million cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant | Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study) | CD4+ T lymphocyte percentages will be obtained from lab reports |
| Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant | up to 48 weeks (End of study) | Data for kidney graft rejection will be extracted from biopsy confirmed rejections. |
| Participant Satisfaction With Reduced Pill Burden and Adverse Events (Tolerability) Measured by the Health-related Quality of Life Questionnaire | Week 24, Week 48 (End of study) | 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. |
| Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant | Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study) | Number of CD4+ T lymphocyte counts will be obtained from lab reports |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) Participants receive a BIC/F/TAF tablet orally once daily with or without food. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 5 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
Intracellular TAF Levels as Measured by Dried Blood Spot
Fmol/punch refers to the concentration of a substance, measured in femtomoles per a specific size of a dried blood spot (DBS) punch.
Time frame: 12 weeks
Population: One subject was excluded from data analysis due to early withdrawal.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Intracellular TAF Levels as Measured by Dried Blood Spot | Tenofovir-diphosphate (TFV-DP) | 1.71 Femtomole (fmol)/punch of DBS |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Intracellular TAF Levels as Measured by Dried Blood Spot | Emtricitabine triphosphate (FTC-TP) | 1.18 Femtomole (fmol)/punch of DBS |
Primary
Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs)
pmol/10\^6 cells refers to the amount of a particular substance (in picomoles) per one million cells
Time frame: 12 weeks
Population: One subject was excluded from data analysis due to early withdrawal.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs) | TFV-DP | 2.87 pmol/10^6 cells |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs) | FTC-TP | 2.76 pmol/10^6 cells |
Primary
Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml
HIV viral loads will be obtained from lab reports.
Time frame: Up to week 48 (End of Study)
Population: One subject was excluded from data analysis due to early study withdrawal.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml | 19 Participants |
Primary
Renal Function as Measured by Blood Urea Nitrogen (BUN)
Time frame: 24 weeks, 48 weeks (End of study)
Population: One subject was excluded from data analysis due to early withdrawal.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Renal Function as Measured by Blood Urea Nitrogen (BUN) | week 24 | 25.21 mg/dL | Standard Deviation 9.06 |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Renal Function as Measured by Blood Urea Nitrogen (BUN) | week 48 | 23.47 mg/dL | Standard Deviation 9.62 |
Primary
Renal Function as Measured by Creatinine
Time frame: 24 weeks, 48 weeks (End of study)
Population: One subject was excluded from data analysis due to early withdrawal.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Renal Function as Measured by Creatinine | week 24 | 1.61 mg/dL | Standard Deviation 0.52 |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Renal Function as Measured by Creatinine | week 48 | 1.57 mg/dL | Standard Deviation 0.52 |
Primary
Renal Function as Measured by Creatinine Clearance
Time frame: 24 weeks, 48 weeks (End of study)
Population: One subject was excluded from data analysis due to early withdrawal.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Renal Function as Measured by Creatinine Clearance | Week 24 | 58.10 mL/min | Standard Deviation 15.92 |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Renal Function as Measured by Creatinine Clearance | week 48 | 60.68 mL/min | Standard Deviation 15.78 |
Primary
Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)
Time frame: 24 weeks, 48 weeks (End of study)
Population: One subject was excluded from data analysis due to early withdrawal.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR) | week 24 | 48.32 mL/min/1.73m^2 | Standard Deviation 13.98 |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR) | week 48 | 49.21 mL/min/1.73m^2 | Standard Deviation 14.84 |
Primary
Safety (Tolerability) as Measured by the Number of Subjects Who Had a Serious Adverse Event (SAE)
Time frame: Up to week 48 (End of study)
Population: One subject was excluded from data analysis due to early withdrawal.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Safety (Tolerability) as Measured by the Number of Subjects Who Had a Serious Adverse Event (SAE) | 1 Participants |
Primary
Tacrolimus Levels
Time frame: 12 weeks, 24 weeks, 48 weeks (End of study)
Population: One subject was excluded from data analysis due to early withdrawal.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Tacrolimus Levels | week 12 | 6.37 ng/mL | Standard Deviation 1.78 |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Tacrolimus Levels | week 24 | 7.97 ng/mL | Standard Deviation 3.29 |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Tacrolimus Levels | week 48 | 6.64 ng/mL | Standard Deviation 2.6 |
Secondary
Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant
Number of CD4+ T lymphocyte counts will be obtained from lab reports
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant | Baseline | 256.5263 cells/µL |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant | Week 4 | 305.8333 cells/µL |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant | Week 12 | 342.2105 cells/µL |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant | Week 24 | 374.8947 cells/µL |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant | Week 36 | 404.6667 cells/µL |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant | Week 48 (End of Study) | 382.4211 cells/µL |
Secondary
Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant
CD4+ T lymphocyte percentages will be obtained from lab reports
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant | Baseline | 22.6842 Percentage of CD4+ lymphocytes |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant | Week 4 | 25.667 Percentage of CD4+ lymphocytes |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant | Week 12 | 25.7368 Percentage of CD4+ lymphocytes |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant | Week 24 | 27.0526 Percentage of CD4+ lymphocytes |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant | Week 36 | 28.1111 Percentage of CD4+ lymphocytes |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant | Week 48 (End of Study) | 26.1579 Percentage of CD4+ lymphocytes |
Secondary
Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant
Data for kidney graft rejection will be extracted from biopsy confirmed rejections.
Time frame: up to 48 weeks (End of study)
Population: 1 participant was excluded from data analysis due to early withdrawal.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant | 0 Participants |
Secondary
Participant Satisfaction With Reduced Pill Burden and Adverse Events (Tolerability) Measured by the Health-related Quality of Life Questionnaire
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.
Time frame: Week 24, Week 48 (End of study)
Population: One subject was excluded from data analysis due to early withdrawal.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | 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 |
| Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) | 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 |