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

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

Study Overview

• Status: Completed
• Conditions: HIV Infections; Proteinuria
• Intervention / Treatment: Drug: change from tenofovir to raltegravir

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Isentress

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients With Reduced or Resolved Proteinuria	Measurement of Protein in Urine samples at end of study visit	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients Without HIV Re-bound	HIV Viral load blood test at week 24	24 weeks

Collaborators and Investigators

• Sponsor: Metropolis Medical
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Fritz Bredeek, MD, Metropolis Medical

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: January 6, 2010
• First Submitted That Met QC Criteria: January 7, 2010
• First Posted (Estimate): January 8, 2010

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 8, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: HIV; Human immunodeficiency virus; tenofovir; viread; truvada; proteinuria
• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Urination Disorders; Proteinuria; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Tenofovir; Raltegravir Potassium
• Other Study ID Numbers: RALPIR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No