NCT00356616

Immuno-Virological Efficacy of Combination With Trizivir +Tenofovir in Multiresistant HIV Patients

Open-Label, Single-Centre, Randomised Pilot Study to Evaluate Immunovirological and Clinical Evolution of a Combination With Nucleoside Analogues/Nucleotides (Trizivir +Tenofovir) in Multiresistant Patients With Virological Failure

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate whether the combined therapy of two nucleosides plus one nucleotide (Trizivir + TDF) manages to keep CD4 lymphocytes stable in patients with HIV infection on antiretroviral treatment that present virological failure and multiple resistance to antiretrovirals.

Detailed description

This study has been designed to determine whether the use of a regimen based exclusively on NTRI, containing tenofovir, zidovudine and lamivudine, is able to preserve immunological status in patients with detectable viral load for whom an efficacious salvage regimen cannot be designed, slowing the progression of the viral load and reducing antiretroviral treatment-associated toxicity. In order to complete the salvage regimen without increasing the number of tablets too much, Trizivir plus tenofovir as investigational treatment will be used.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Trizivir (AZT+3HT+Abacavir) twice daily	Trizivir (AZT+3HT+Abacavir) twice daily
DRUG	Viread (300 mg Tenofovir disoproxil fumarate) once daily	Viread (300 mg Tenofovir disoproxil fumarate) once daily

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2006-07-26
• Last updated: 2008-01-29

Locations

1 site across 1 country: Spain