NCT01044771

Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Metropolis Medical · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

Conditions

• HIV Infections
• Proteinuria

Interventions

Type	Name	Description
DRUG	change from tenofovir to raltegravir	Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-12-01
• Completion: 2011-06-01
• First posted: 2010-01-08
• Last updated: 2015-05-12
• Results posted: 2015-05-12