NCT01034917

Switching From Protease Inhibitor (PI) to Etravirine in HIV-1 Infected Subjects With Viremia Suppression

Pilot Study to Assess the Efficacy and Safety of Switching Protease Inhibitor to Etravirine in HIV-1-infected Subjects With Viremia Suppression

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial. Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same approach. The aim of the study is to compare the virological efficacy of the etravirine-based regimen with standard PI-containing regimen.

Detailed description

Etravirine is a second generation non-nucleoside analogue reverse transcriptase inhibitor (NNRTI) approved by the U.S. Food and Drug Administration (FDA) in January 2008 and by the European Medicines Agency in September 2008 for clinical use in adults with incomplete virologic suppression and resistance to previous NNRTI and other antiretroviral classes. A question that has not been explored is whether subjects with sustained undetectable HIV-1 RNA-levels experiencing antiretroviral-related toxicity can safely switch their current PI to etravirine. This treatment strategy could allow improvements in tolerability and lipid profile and would permit an easy posology (400 mg dissolved in water every 24 hours). We designed a proof-of-concept study to test the efficacy and safety of switching from a Protease Inhibitor (PI) to etravirine in subjects with viral suppression as an antiretroviral strategy of simplification therapy, based on the high antiviral potency, low toxicity, together with its easy posology (in water dissolution). Patients with HIV-1 infection on HAART PI-based regimen will be randomized to switch from the PI to etravirine (400 mg dissolved in water every 24 hours) or to continue with the same approach. The primary endpoint would be the percentage of patients who maintain virological suppression at week 48.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Etravirine 400 mg dissolved in water every 24 hours	Switch from the PI to Etravirine 400 mg dissolved in water every 24 hours
DRUG	Continue with the same antiretroviral regimen	Continue with the same antiretroviral regimen

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-12-18
• Last updated: 2020-01-31

Locations

1 site across 1 country: Spain