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

Brief 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

Condition or disease Intervention/treatment
HIV Infections Proteinuria Drug: change from tenofovir to raltegravir

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Primary Completion Date : December 2010
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Patients With Reduced or Resolved Proteinuria [ Time Frame: 24 weeks ]
    Measurement of Protein in Urine samples at end of study visit

Secondary Outcome Measures :
  1. Patients Without HIV Re-bound [ Time Frame: 24 weeks ]
    HIV Viral load blood test at week 24

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01044771

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

Responsible Party: Fritz Bredeek, MD, PhD, President, Metropolis Medical Identifier: NCT01044771     History of Changes
Other Study ID Numbers: RALPIR
First Posted: January 8, 2010    Key Record Dates
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Fritz Bredeek, MD, PhD, Metropolis Medical:
Human immunodeficiency virus

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Raltegravir Potassium
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors