Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria (RALPIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01044771
Recruitment Status : Completed
First Posted : January 8, 2010
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Fritz Bredeek, MD, PhD, Metropolis Medical

January 6, 2010
January 8, 2010
January 20, 2014
May 12, 2015
May 12, 2015
January 2010
December 2010   (Final data collection date for primary outcome measure)
Patients With Reduced or Resolved Proteinuria [ Time Frame: 24 weeks ]
Measurement of Protein in Urine samples at end of study visit
Proportion of patients with reduced or resolved proteinuria [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT01044771 on Archive Site
Patients Without HIV Re-bound [ Time Frame: 24 weeks ]
HIV Viral load blood test at week 24
Proportion of patients with undetectable HIV viral load [ Time Frame: 24 weeks ]
Not Provided
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Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria
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

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

As described in the brief summary, this is a pilot study to evaluate for improvements in proteinuria when switched off from Tenofovir
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV Infections
  • Proteinuria
Drug: change from tenofovir to raltegravir
Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID
Other Name: Isentress
change from tenofovir to raltegravir

Single arm study:

Tenofovir containing nucleoside backbone changed over to raltegravir in all patients

Intervention: Drug: change from tenofovir to raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2011
December 2010   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
Not Provided
Not Provided
Fritz Bredeek, MD, PhD, Metropolis Medical
Metropolis Medical
Merck Sharp & Dohme Corp.
Principal Investigator: Fritz Bredeek, MD Metropolis Medical
Metropolis Medical
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP