Trial | NCT01044771  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Study Participants

    20
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
Study Started
Jan 31
2010
Primary Completion
Dec 31
2010
Study Completion
Jun 30
2011
Results Posted
May 12
2015
Estimate
Last Update
May 12
2015
Estimate

Drug change from tenofovir to raltegravir

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

  • Other names: Isentress

change from tenofovir to raltegravir Other

Single arm study: Tenofovir containing nucleoside backbone changed over to raltegravir in all patients

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)

Summary

Change From Tenofovir to Raltegravir

All Events

Event Type Organ System Event Term

Patients With Reduced or Resolved Proteinuria

Measurement of Protein in Urine samples at end of study visit

Change From Tenofovir to Raltegravir

20.0
participants

Patients Without HIV Re-bound

HIV Viral load blood test at week 24

Viral Rebound

2.0
participants

Age, Categorical

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

Change From Tenofovir to Raltegravir