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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
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

January 6, 2010
October 25, 2012
January 2010
December 2010   (final data collection date for primary outcome measure)
Proportion of patients with reduced or resolved proteinuria [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01044771 on ClinicalTrials.gov Archive Site
Proportion of patients with undetectable HIV viral load [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01044771
RALPIR
Yes
Fritz Bredeek, MD, PhD, Metropolis Medical
Metropolis Medical
Merck Sharp & Dohme Corp.
Principal Investigator: Fritz Bredeek, MD Metropolis Medical
Metropolis Medical
October 2012

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