Clinical Trial: Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: As described in the brief summary, this is a pilot study to evaluate for improvements in proteinuria when switched off from Tenofovir
Sponsor: Metropolis Medical

Current Primary Outcome: Patients With Reduced or Resolved Proteinuria [ Time Frame: 24 weeks ]

Measurement of Protein in Urine samples at end of study visit


Original Primary Outcome: Proportion of patients with reduced or resolved proteinuria [ Time Frame: 24 weeks ]

Current Secondary Outcome: Patients Without HIV Re-bound [ Time Frame: 24 weeks ]

HIV Viral load blood test at week 24


Original Secondary Outcome: Proportion of patients with undetectable HIV viral load [ Time Frame: 24 weeks ]

Information By: Metropolis Medical

Dates:
Date Received: January 6, 2010
Date Started: January 2010
Date Completion:
Last Updated: May 8, 2015
Last Verified: May 2015