Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04530630|
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : November 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Renal Transplant Rejection||Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 9, 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||December 2022|
Participants receive a Biktarvy tablet orally once daily with or without food.
Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet
A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide.
- Proportion of subjects with plasma HIV-1 RNA <50 copies/ml [ Time Frame: Week 48 ]HIV viral loads will be obtained from lab reports
- Safety, as measured by number of participants with at least one adverse event [ Time Frame: Approximately 1 month after final study visit ]Adverse events will only include those that are determined to be related to the study drug
- Change in tolerated dose of Biktarvy in HIV positive post renal transplant participants as measured by HIV Treatment Satisfaction Questionnaire [ Time Frame: Week 4, Week 12, Week 24, Week 36, Week 48, 3 Month Follow Up, 6 Month Follow Up ]Tolerability will be measured by the health-related quality of life questionnaire to assess satisfaction with a one pill regimen. The health-related questionnaire ranges from 0 to 6 with higher scores indicating greater satisfaction.
- Change in interaction between plasma concentrations for Bictegravir/Emtricitabine/Tenofovir alafenamide, intracellular TAF levels, tacrolimus levels, and renal function [ Time Frame: 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 ]Relationships will be determined by linear regression analysis.
- Change from baseline in CD4+ T lymphocyte cell count/percentages post renal transplant [ Time Frame: Day 1, Week 4, Week 12, Week 24, Week 36, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up ]CD4 lymphocyte counts and percentages will be obtained from lab reports
- Correlation between rejection rates of the kidney transplant post renal and Tacrolimus levels [ Time Frame: Approximately 3 months after primary outcome completion ]Data for kidney graft rejection rates will be extracted from biopsy confirmed rejections and observed along with levels of Tacrolimus obtained from blood samples.
- Change in participants satisfaction with reduced pill burden, as measured by the health-related quality of life questionnaire [ Time Frame: Week 4, Week 12, Week 24, Week 36, Week 48 (End of study), 3 Month Follow Up, 6 Month Follow Up ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530630
|Contact: Anna Gwak, BAfirstname.lastname@example.org|
|Contact: Elizabeth L Salsgiver, MPHemail@example.com|
|United States, New York|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10065|
|Contact: Anna Gwak, BA 212-746-4089 firstname.lastname@example.org|
|Contact: Elizabeth L Salsgiver, MPH 2127464089 email@example.com|
|Principal Investigator: Catherine B Small, MD|
|Principal Investigator:||Catherine B Small, MD||Weill Medical College of Cornell University|