There is one clinical trial.
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.
NCT00356616 Conditions
- HIV Infections
Interventions
- Drug: Trizivir (AZT+3HT+Abacavir) twice daily
- Drug: Viread (300 mg Tenofovir disoproxil fumarate) once daily
5. Genotype or phenotype resistance to three families of antiretrovirals (PI, NTRI and
NNRTI) demonstrated in genotype study carried out in the last 48 weeks and defined as:
- 3 or more TAMS of the following: M41L, E44D, D67N, V118I, L210W, T215Y/F,
K219Q/E. --- M41L --- --- E44D --- --- D67N --- --- V118I ---
Primary Outcomes
Measure: Variations in the immune status of patients in each group throughout follow-up. Time: 48 weeks
Secondary Outcomes
Measure: Percentage of patients that increase viral load by > 0.5 log Time: weeks 12, 24, 36 and 48
Measure: Percentage of patients that increase viral load by > 100,000 copies/mL Time: weeks 12, 24, 36 and 48
Measure: Percentage of patients that present some clinical event, B or C classification according to the CDC. Time: during the 48 weeks of follow-up
Measure: Percentage of patients that present clinical or analytical adverse effects degree > 2 according to the WHO classification. Time: weeks 12, 24, 36 and 48
Measure: Percentage of patients that drop out of treatment. Time: weeks 12, 24, 36 and 48
Measure: Percentage of patients that drop out of the study due to intolerance or adverse effects. Time: weeks 12, 24, 36 and 48
Measure: Percentage of change in lipid determinations. Time: weeks 12, 24, 36 and 48 with regard to baseline
Measure: Percentage of patients that report changes, improvement or worsening in redistribution of body fat. Time: weeks 12, 24, 36 and 48
Measure: Percentage of patients that present adherence to the antiretroviral treatment > 95%. Time: weeks 12, 24, 36 and 48
Measure: Percentage of patients that present improvement in the quality of life (MOS-HIV) and satisfaction questionnaires. Time: weeks 12, 24, 36 and 48
Measure: Percentage of patients that present an increase in the number of active drugs. Time: at the end of the study