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NCT Number: NCT01044771

Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria

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

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Proteinuria RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Slow Virus Diseases Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

change from tenofovir to raltegravir

Drug

Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID

Other names: Isentress

Primary outcomes

  1. Patients With Reduced or Resolved Proteinuria

    Time frame: 24 weeks

    Measurement of Protein in Urine samples at end of study visit

Secondary outcomes

  1. Patients Without HIV Re-bound

    Time frame: 24 weeks

    HIV Viral load blood test at week 24

Sponsors and collaborators

Lead sponsor

Metropolis Medical

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: RALPIR

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jan 8, 2010
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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