Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
The study is designed to evaluate the proportion of patients with tenofovir induced
proteinuria that will resolve their proteinuria when the tenofovir containing
nucleoside/nucleotide backbone is switched to a raltegravir backbone. Common HIV treatment
regimens contain nucleoside/nucleotide combinations that may have long-term side effects
including nephrotoxicity. Switching these backbones out for an integrase inhibitor based
regimen has not been systematically evaluated.
Hypothesis: Proteinuria developing during treatment with tenofovir improves or resolves when
tenofovir is switched out with raltegravir. Switching to a nuc- sparing regimen, containing
raltegravir and a boosted protease inhibitor in patients without preexisting protease
inhibitor mutations is safe and does not lead to virologic failure