Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria

HIV Infections Clinical Trial

— RALPIR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044771
• Other study ID #: RALPIR
• Status: Completed
• Phase: N/A
• First received: January 6, 2010
• Last updated: May 8, 2015
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2015
• Source: Metropolis Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Proteinuria

Intervention

Drug:
• change from tenofovir to raltegravir
Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Metropolis Medical	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients With Reduced or Resolved Proteinuria	Measurement of Protein in Urine samples at end of study visit	24 weeks	Yes
Secondary	Patients Without HIV Re-bound	HIV Viral load blood test at week 24	24 weeks	Yes