Switching to tenofovir alafenamide fumarate or abacavir in patients with renal impairment due to tenofovir disoproxil fumarate.

Switching to Tenofovir Alafenamide Fumarate or ABACavir in patients with Tenofovir Disoproxil Fumarate associated eGFR decline. A randomized clinical trial. - BACTAF

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005045-31-NL

Enrollment

Unknown

Registered

2016-02-25

Start date

2016-09-13

Completion date

Unknown

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal safety of switching from TDF to TAF or ABC in patients with TDF-associated eGFR-decline.

Interventions

Trade Name: Descovy Product Code: FTC/TAF 200mg/10mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: EMTRICITABINE CAS Number: 143491-57-0 Current Sponsor code: FTC Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 18 years or older HIV-positive with HIV-RNA =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Chronic hepatitis B or C Symptomatic arterial disease e.g. a history of coronary artery disease, ischemic cerebrovascular accident or claudication intermittens in medical history Not meeting all inclusion-criteria as mentioned above

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the renal safety when HIV patients with TDF related renal toxicity switch to TAF compared to the current practice of switching to ABC.;Secondary Objective: To evaluate effect and safety of a switch from TDF to TAF or ABC on viral suppression, markers of proximal tubular dysfunction, other biochemical markers (liver, lipids, inflammation), bone mineral density, Framingham risk score.;Primary end point(s): To evaluate the extent of recovery of TDF-based eGFR decline in the TAF-arm versus the ABC-arm at week 48 after the switch from TDF. Recovery is defined as the time to the first eGFR during follow up to within 85% of the eGFR at TDF initiation;Timepoint(s) of evaluation of this end point: week 48	—

Measure

Time frame

Main Objective: To study the renal safety when HIV patients with TDF related renal toxicity switch to TAF compared to the current practice of switching to ABC.;Secondary Objective: To evaluate effect and safety of a switch from TDF to TAF or ABC on viral suppression, markers of proximal tubular dysfunction, other biochemical markers (liver, lipids, inflammation), bone mineral density, Framingham risk score.;Primary end point(s): To evaluate the extent of recovery of TDF-based eGFR decline in the TAF-arm versus the ABC-arm at week 48 after the switch from TDF. Recovery is defined as the time to the first eGFR during follow up to within 85% of the eGFR at TDF initiation;Timepoint(s) of evaluation of this end point: week 48

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Secondary

Measure	Time frame
Secondary end point(s): • The between group differences (TAF vs ABC) with respect to the time to recovery of renal dysfunction at week 96, with adjustment for potential important confounders. • HIV-RNA suppression rate 10%, uPCR >15 with uAPR<0.4, non-anion gap metabolic acidosis) within and between groups. • Framingham risk-score, inflammation parameters, blood pressure, pulse rate and lipids will be evaluated between groups and within groups at week 0, 48 and 96. • Bone mineral density (BMD) of spine and hip will be compared in and between groups (ABC, TAF) at week 0, 48 and 96. ;Timepoint(s) of evaluation of this end point: Week 0, Week 48, Week 96	—

Measure

Time frame

Secondary end point(s): • The between group differences (TAF vs ABC) with respect to the time to recovery of renal dysfunction at week 96, with adjustment for potential important confounders. • HIV-RNA suppression rate 10%, uPCR >15 with uAPR<0.4, non-anion gap metabolic acidosis) within and between groups. • Framingham risk-score, inflammation parameters, blood pressure, pulse rate and lipids will be evaluated between groups and within groups at week 0, 48 and 96. • Bone mineral density (BMD) of spine and hip will be compared in and between groups (ABC, TAF) at week 0, 48 and 96. ;Timepoint(s) of evaluation of this end point: Week 0, Week 48, Week 96

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Countries

Netherlands

Contacts

Public ContactCoordinerend onderzoeker

Erasmus MC

i.wijting@erasmusmc.nl+31631090143

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026