Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Metropolis Medical
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Raltegravir Potassium; Tenofovir

Criteria

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)