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

Phase 3

Completed

• Conditions: AIDS; HIV; 10021460; 10047438

• Registration Number: NL-OMON46033
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

* 18 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 3th agent for at least 1 month .
* HIV-1 RNA <50 copies/mL for * 6 months.
* Confirmed/probable TDF-related accelerated eGFR decline
* Concomittantly used medication does not interfere with trial procedures (on investigators* discretion).
* Patient is negative for the HLA B5701 allele.

Exclusion Criteria

* Likely other cause of non-TDF-related accelerated GFR decline:
* Diabetic patients
* Hypertensive patients (defined as the use of more than 2 antihypertensives or untreated systolic (>=160mmHg) or diastolic (>=95mmHg) hypertension) or hypertension with use of antihypertensives and with proteinuria at the screening visit..
* 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.;* HLA-B5701 positivity.
* Active hepatitis C or B.
- Intermediate or high level resistance to ABC
- eGFR <30 ml/min
Symptomatic arterial disease e.g. a history of coronary artery disease, ischemic cerebrovascular accident or claudication intermittens in medical history.
* 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Recovery of renal dysfunction in the TAF arm versus the ABC arm at 48 weeks<br /><br>after the switch from TDF to TAF or ABC using the time to the first eGFR within<br /><br>75% of the eGFR at the time of TDF initiation. </p><br>