Clinical trial NCT04530630: Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant
Official title: The Efficacy, Safety, and Tolerability of Switching to a Bictegravir (BIC)/Emtricitabine(FTC)/Tenofovir Alafenamide (TAF) Regimen in Virally Suppressed HIV-Positive Patients Post-Renal Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Renal Transplant Rejection
Keywords: HIV Positive
Post Renal Transplant
Bictegravir/Emtricitabine/Tenofovir Alafenamide
Antiretroviral
Biktarvy
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2020-08-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label study, where participants will be switched from their current HIV medication to the study drug, Biktarvy. 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 Biktarvy. The investigator hypothesizes that Biktarvy 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.


Eligibility criteria: 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 Biktarvy for treatment of HIV
* Has allergies to any of the HIV medications in Biktarvy (bictegravir, emtricitabine, or tenofovir alafenamide)
* Currently taking dofetilide or rifampin
* Is pregnant or breastfeeding

Primary outcomes:
measure: Proportion of subjects with plasma HIV-1 RNA <50 copies/ml
timeFrame: Week 48
measure: Safety, as measured by number of participants with at least one adverse event
timeFrame: Approximately 1 month after final study visit
measure: Change in tolerated dose of Biktarvy in HIV positive post renal transplant participants as measured by HIV Treatment Satisfaction Questionnaire
timeFrame: Week 4, Week 12, Week 24, Week 36, Week 48, 3 Month Follow Up, 6 Month Follow Up
measure: Change in interaction between plasma concentrations for Bictegravir/Emtricitabine/Tenofovir alafenamide, intracellular TAF levels, tacrolimus levels, and renal function
timeFrame: Day 1, Day 3, Day 5, Day 8, Day 11, Day 22, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up
Secondary outcomes:
measure: Change from baseline in CD4+ T lymphocyte cell count/percentages post renal transplant
timeFrame: Day 1, Week 4, Week 12, Week 24, Week 36, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up
measure: Correlation between rejection rates of the kidney transplant post renal and Tacrolimus levels
timeFrame: Approximately 3 months after primary outcome completion
measure: Change in participants satisfaction with reduced pill burden, as measured by the health-related quality of life questionnaire
timeFrame: Week 4, Week 12, Week 24, Week 36, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Catherine B Small, MD
role: PRINCIPAL_INVESTIGATOR
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