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Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria

Information source: Metropolis Medical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Proteinuria

Intervention: change from tenofovir to raltegravir (Drug)

Phase: N/A

Status: Completed

Sponsored by: Metropolis Medical

Official(s) and/or principal investigator(s):
Fritz Bredeek, MD, Principal Investigator, Affiliation: Metropolis Medical

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

Clinical Details

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 Viral Loads

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Patients With Reduced or Resolved Proteinuria

Secondary outcome: Patients Without HIV Re-bound

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Additional Information

Starting date: January 2010
Last updated: May 8, 2015

Page last updated: August 23, 2015

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