NCT00958100

Raltegravir Switch for Toxicity or Adverse Events

Phase IIb Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Tenofovir+Emtricitabine+Raltegravir or to Lamivudine+Abacavir+Raltegravir in Patients With Optimal Virological Control and Toxicity to the Current Combined Antiretroviral Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabine + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies needing a therapeutic switch for toxicity related issues or adverse events.

Conditions

• HIV/AIDS
• Antiretroviral Therapy
• HIV Infections

Interventions

Type	Name	Description
DRUG	tenofovir emtricitabine raltegravir	switch from current antiretroviral regimen to raltegravir with tenofovir/emtricitabine as backbone
DRUG	Lamivudine Abacavir Raltegravir	Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone
DRUG	Abacavir free	Patients will receive raltegravir with tenofovir/emtricitabine; data will be added to those of Tenofovir Emtricitabine Raltegravir arm in a separate longitudinal analysis comparing data at baseline and at 48 weeks. In this separate analysis, data will not be compared to those obtained from the Lamivudine Abacavir Raltegravir arm. The number of patients in this arm is not pre-established.

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-11-01
• Completion: 2010-12-01
• First posted: 2009-08-13
• Last updated: 2015-02-04

Locations

1 site across 1 country: Italy