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
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