Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria

NCT ID: NCT01044771

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-06-30

Brief 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

Detailed Description

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

Conditions

HIV Infections; Proteinuria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

change from tenofovir to raltegravir

Single arm study:

Tenofovir containing nucleoside backbone changed over to raltegravir in all patients

Group Type: OTHER

change from tenofovir to raltegravir

Intervention Type: DRUG

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

Interventions

change from tenofovir to raltegravir

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

Intervention Type: DRUG

Other Intervention Names

Isentress

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Metropolis Medical

OTHER

Sponsor Role: lead

Responsible Party

Fritz Bredeek, MD, PhD

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fritz Bredeek, MD

Role: PRINCIPAL_INVESTIGATOR

Metropolis Medical

Other Identifiers

RALPIR

Identifier Type: -

Identifier Source: org_study_id