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

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Fritz Bredeek, MD, PhD, Metropolis Medical
ClinicalTrials.gov Identifier:
NCT01044771
First received: January 6, 2010
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Phase
HIV Infections
Proteinuria
 Drug: change from tenofovir to raltegravir
 Phase 4

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:

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

Further study details as provided by Metropolis Medical:

Primary Outcome Measures:
  • Proportion of patients with reduced or resolved proteinuria [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of patients with undetectable HIV viral load [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044771

Sponsors and Collaborators
Metropolis Medical
Merck
Investigators
Principal Investigator: Fritz Bredeek, MD Metropolis Medical
  More Information

No publications provided

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
Last Updated: October 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Metropolis Medical:
HIV
Human immunodeficiency virus
tenofovir
 viread
truvada
proteinuria

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Proteinuria
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Urination Disorders
Urologic Diseases
 Urological Manifestations
Signs and Symptoms
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 22, 2013