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

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Fritz Bredeek, MD, PhD, Metropolis Medical
ClinicalTrials.gov Identifier:
First received: January 6, 2010
Last updated: May 8, 2015
Last verified: May 2015

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

Condition Intervention
HIV Infections
Drug: change from tenofovir to raltegravir

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Metropolis Medical:

Primary Outcome Measures:
  • Patients With Reduced or Resolved Proteinuria [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Measurement of Protein in Urine samples at end of study visit

Secondary Outcome Measures:
  • Patients Without HIV Re-bound [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    HIV Viral load blood test at week 24

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
change from tenofovir to raltegravir

Single arm study:

Tenofovir containing nucleoside backbone changed over to raltegravir in all patients

Drug: change from tenofovir to raltegravir
Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID
Other Name: Isentress

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01044771

Sponsors and Collaborators
Metropolis Medical
Merck Sharp & Dohme Corp.
Principal Investigator: Fritz Bredeek, MD Metropolis Medical
  More Information

Responsible Party: Fritz Bredeek, MD, PhD, President, Metropolis Medical
ClinicalTrials.gov Identifier: NCT01044771     History of Changes
Other Study ID Numbers: RALPIR 
Study First Received: January 6, 2010
Results First Received: January 20, 2014
Last Updated: May 8, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Metropolis Medical:
Human immunodeficiency virus

Additional relevant MeSH terms:
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Raltegravir Potassium
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016