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

Phase 1

Conditions: Renal safety of switching from TDF to TAF or ABC in patients with TDF-associated eGFR-decline.
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2015-005045-31-NL

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

18 years or older
HIV-positive with HIV-RNA <50 c/ml for at least 6 months
Stable on TDF/FTC or TDF/3TC for at least 12 months, in combination with a 3rd antiretroviral agent
Confirmed/probable TDF-related eGFR-decline with absence of other causes of eGFR-decline.
HLA-B5701 allele negative
General medication and condition does not interfere with trial procedure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures