Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria (RALPIR)

A Pilot Study to Evaluate the Effectiveness of a Tenofovir Raltegravir Switch in Resolving Tenofovir Induced Proteinuria in HIV Infected Individuals With Undetectable HIV Viral Loads

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

As described in the brief summary, this is a pilot study to evaluate for improvements in proteinuria when switched off from Tenofovir

Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients

Inclusion Criteria: Documented HIV infection Ability to comply to protocol requirements On stable HAART for minimum of 12 weeks Evidence of TDF induced proteinuria No evidence of prior Protease inhibitor failure Treatment-naïve to integrase inhibitors VL<200 x 12 weeks (minimum of 2 viral load measurements) Exclusion Criteria: Active Hepatitis B infection Proteinuria predating tenofovir use PRAMs on historic GT or PT Life expectancy less than 6 months Subjects with any ongoing AIDS defining illness Any condition which could compromise the safety of study subject Grade 3 or 4 lab abnormalities (excl. grade 3 bilirubin elevations)