Switching From Tenofovir Disoproxil Fumarate to Abacavir or Tenofovir Alafenamide
BACTAF
Switching to Tenofovir Alafenamide Fumarate or Abacavir in Patients With Tenofovir Disoproxil Fumarate Associated eGFR Decline. A Randomized Trial.
1 other identifier
interventional
80
1 country
5
Brief Summary
Tenofovir disoproxil fumarate (TDF) is one of the most frequently used drugs to treat HIV. Long term use of TDF can induce renal toxicity. Tenofovir alafenamide (TAF) is a new pro-drug of Tenofovir which has not been associated with renal toxicity and may therefore be a good substitute for TDF in patients with TDF induced renal toxicity. Abacavir (ABC) is another drug that can be used for the treatment of HIV and is not associated with renal toxicity. In this study the investigators will compare the effect on renal function of a switch from TDF to TAF with a switch from TDF to ABC in patients with TDF induced renal insufficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2016
Longer than P75 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 4, 2016
CompletedFirst Posted
Study publicly available on registry
November 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedJanuary 28, 2020
January 1, 2020
3.7 years
November 4, 2016
January 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Recovery of renal insufficiency
Recovery of renal dysfunction in the TAF arm versus the ABC arm at 48 weeks after the switch from TDF to TAF or ABC using the time to the first eGFR within 75% of the eGFR at the time of TDF initiation.
48 weeks
Secondary Outcomes (7)
Time to recovery of renal dysfunction
96 weeks
Slope of eGFR-decline/increase
96 weeks
Recovery of proteinuria
96 weeks
Recovery of proximal tubular dysfunction
96 weeks
plasma HIV RNA <50c/ml
96 weeks
- +2 more secondary outcomes
Study Arms (2)
Switch to tenofovir alafenamide
EXPERIMENTALSwitch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide
Switch to abacavir
ACTIVE COMPARATORSwitch from tenofovir disoproxil fumarate (TDF) to abacavir
Interventions
Eligibility Criteria
You may qualify if:
- HIV-positive documented by ELISA or Western Blot or plasma HIV-RNA \> 1000 copies/mL.
- years or older. Stable on TDF/FTC or TDF/3TC for ≥12 months (365 days) in combination with a third antiretroviral agent (NNRTI, INI, or PI) and with an unchanged third agent for at least 1 month.
- HIV-1 RNA \<50 copies/mL for ≥ 6 months. Patient is negative for the HLA B5701 allele.
- Confirmed/probable TDF-related accelerated eGFR decline (one of the following):
- Accelerated eGFR decline: mean of \> 3 mL/min/year since start TDF after ≥5 years of TDF exposure.
- Confirmed eGFR \< 70 mL/min in patients with baseline eGFR \> 90 mL/min at start of TDF.
- eGFR decrease \> 25% compared to baseline eGFR at TDF-initiation.
- Absence of other causes of eGFR decline:
- Diabetic patients with diabetic nephropathy (defined as an eGFR decline and uACR\>30mg/mmol with uAPR \>/=0.4, or biopsy proven).
- Hypertensive patients (defined as the use of antihypertensives or untreated systolic (\>=160mmHg) or diastolic (\>=95mmHg) hypertension) in combination with hypertensive nephropathy (defined as eGFR decline with uACR\>30mg/mmol with uAPR\>/=0.4, or biopsy proven).
- Nephrotic syndromes/nephrotic range proteinuria (uACR \>300mg/mmol and uAPR ≥ 0.4, or total 24hrs proteinuria \>3.5g/24hr, or biopsy proven) Nephrotic syndromes including rapid progressive glomerulonephritis and tubular interstitial nephritis (defined as active urine sediment with erythrocyturia and leucocyturia and proteinuria with eGFR decline, with or without the presence of systemic disease, or biopsy proven).
- Obvious other renal toxic effects related to lifestyle or medication (e.g. creatin use) suspected by the investigators or biopsy proven.
- Concomittantly used medication does not interfere with trial procedures (on investigators' discretion).
You may not qualify if:
- Likely other cause (as defined above) of the accelerated GFR decline. HLA-B5701 positivity. Active hepatitis C or B. Documented intermediate or high level resistance to ABC. eGFR \<30ml/min. Any other disease or medical condition that, in the opinion of the investigators, would interfere with the safety of the participant or the conduct of the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erasmus Medical Centerlead
- Gilead Sciencescollaborator
Study Sites (5)
Ziekenhuis Rijnstate
Arnhem, Gelderland, Netherlands
MC Slotervaart
Amsterdam, 1066EC, Netherlands
OLVG
Amsterdam, 1091AC, Netherlands
Erasmus MC
Rotterdam, 3000CA, Netherlands
Maasstad ziekenhuis
Rotterdam, 3079DZ, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bart Rijnders, MD PhD
Erasmus Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
November 4, 2016
First Posted
November 8, 2016
Study Start
October 1, 2016
Primary Completion
June 1, 2020
Study Completion
September 1, 2020
Last Updated
January 28, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share