NCT00338390

Study to Evaluate Changes in CD4 on Replacing TDF With ABC or DDI+TDF With ABC+3TC

Study of Changes in CD4 Lymphocyte Count in Patients With a HAART Regimen Including DDI + Tenofovir and With Viral Suppression Following the Replacement of Tenofovir With Abacavir Once Daily or Following the Double Replacement of DDI + Tenofovir With Abacavir + Lamivudine in a Single Tablet

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Hospital de Granollers · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.

Detailed description

Different works have shown a high rate of virological failure among patients on abacavir + lamivudine + tenofovir or ddI + 3TC + tenofovir, thus rendering the use of these combinations actively unadvisable. Furthermore, recent studies have also shown that ABC+3TC are associated with a significantly higher increase in CD4 than the current treatment standard formed by AZT+3TC. This provides us with grounds to suppose that patients with TDF+ddI may recover their CD4 with ABC+3HT. Similarly, and recently, the existence of pharmacokinetic interactions between tenofovir + abacavir has begun to be questioned. Finally, the replacement of tenofovir with abacavir or tenofovir + ddI with abacavir + lamivudine does not detract from the potency of HAART, the toxicity profile is different and their behaviour at mitochondrial level is similar. This study aims to ascertain whether the sole replacement of tenofovir with abacavir once a day improves the immunological response obtained with tenofovir + ddI or whether it is better to perform a double replacement of tenofovir and ddI with abacavir + lamivudine (joint formulation) in a single daily dose to achieve these objectives.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Abacavir	Change tenofovir to abacavir
DRUG	Didanosine	Increase didanosine dose to 400 mg/day if weight is \> 60 Kg. or to 250mg/day if weight is \< 60 kg.
DRUG	Abacavir+Lamivudine	Change tenofovir and didanosine to abacavir + lamivudine (600mg+300 mg/day in one single tablet).

Timeline

• Start date: 2005-04-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2006-06-20
• Last updated: 2015-03-24

Locations

21 sites across 1 country: Spain