Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria
| Status: | Archived |
|---|---|
| Conditions: | HIV / AIDS, Endocrine, Nephrology |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | January 2010 |
| End Date: | October 2010 |
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
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