Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria

Not Applicable

Completed

• Conditions: HIV Infections; Proteinuria
• Interventions: Drug: change from tenofovir to raltegravir

• Registration Number: NCT01044771
• Lead Sponsor: Metropolis Medical

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 Description

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

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Primary Completion: 2010-12
• Study Completion: 2011-06
• Results First Submitted: 2014-01-20
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-08
• Last Update Submitted: 2015-05-08
• Results First Posted: 2015-05-12
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
change from tenofovir to raltegravir	change from tenofovir to raltegravir	Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients

Primary Outcome Measures

Name	Time	Method
Patients With Reduced or Resolved Proteinuria	24 weeks	Measurement of Protein in Urine samples at end of study visit

Secondary Outcome Measures

Name	Time	Method
Patients Without HIV Re-bound	24 weeks	HIV Viral load blood test at week 24