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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Trizivir (AZT+3HT+Abacavir) twice daily
Viread (300 mg Tenofovir disoproxil fumarate) once daily
H.U. Germans Trias i Pujol
Badalona, Barcelona, Spain
Variations in the immune status of patients in each group throughout follow-up.
Time frame: 48 weeks
Percentage of patients that increase viral load by > 0.5 log
Time frame: weeks 12, 24, 36 and 48
Percentage of patients that increase viral load by > 100,000 copies/mL
Time frame: weeks 12, 24, 36 and 48
Percentage of patients that present some clinical event, B or C classification according to the CDC.
Time frame: during the 48 weeks of follow-up
Percentage of patients that present clinical or analytical adverse effects degree > 2 according to the WHO classification.
Time frame: weeks 12, 24, 36 and 48
Percentage of patients that drop out of treatment.
Time frame: weeks 12, 24, 36 and 48
Percentage of patients that drop out of the study due to intolerance or adverse effects.
Time frame: weeks 12, 24, 36 and 48
Percentage of change in lipid determinations.
Time frame: weeks 12, 24, 36 and 48 with regard to baseline
Percentage of patients that report changes, improvement or worsening in redistribution of body fat.
Time frame: weeks 12, 24, 36 and 48
Percentage of patients that present adherence to the antiretroviral treatment > 95%.
Time frame: weeks 12, 24, 36 and 48
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Percentage of patients that present improvement in the quality of life (MOS-HIV) and satisfaction questionnaires.
Time frame: weeks 12, 24, 36 and 48
Percentage of patients that present an increase in the number of active drugs.
Time frame: at the end of the study