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

Metropolis Medical

Status: Completed

Conditions: Proteinuria; HIV Infections

Treatments: Drug: change from tenofovir to raltegravir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01044771

RALPIR

Details and patient eligibility

About

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

Full description

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

change from tenofovir to raltegravir

Other group

Description:

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

Treatment:

Drug: change from tenofovir to raltegravir