Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria

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

Official Title
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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

Conditions
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HIV Infections, Proteinuria

Intervention / Treatment
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* Drug: change from tenofovir to raltegravir


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: change from tenofovir to raltegravir<br>Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients | Drug: change from tenofovir to raltegravir<br>* Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID<br>* Other names: Isentress;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Reduced or Resolved Proteinuria | Measurement of Protein in Urine samples at end of study visit | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Without HIV Re-bound | HIV Viral load blood test at week 24 | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Human immunodeficiency virus, tenofovir, viread, truvada, proteinuria