The current goal of antiretroviral therapy is to use a potent regimen that will suppress plasma viral load and maintain this suppression as long as possible. However, for most patients treated with such potent regimen, several problems can limit their long term effectiveness and contribute to incomplete viral suppression. These problems include poor tolerability, metabolic toxic effects. In order to avoid common problems as toxicity it might be interested to simplify treatment with fewer toxicity, lower pill burden. In this study we will evaluate the safety and efficacy of a simplification treatment with TRIZIVIR in long term after a Boosted PI or NNRTI containing regimen as first line therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
TRIZIVIR
Non-nucleoside reverse transcriptase inhibitor
Boosted Protease Inhibitor
Proportion of patients with a HIV plasma RNA<50 copies/ml at 48 weeks
Proportion of patients with a HIV plasma RNA\<50 copies/ml at 48 weeks
Time frame: 48 weeks
Proportion of patients with a HIV plasma RNA <50copies/ml at 96 weeks.
Proportion of patients with a HIV plasma RNA \<50copies/ml at 96 weeks
Time frame: up to 96 weeks
CD4 count profile at baseline 24 W,48 and 96 W
CD4 count profile at baseline 24,48, and 96 weeks
Time frame: 24, 48, 96 weeks
Genotypic profile resistance
Genotypic profile resistance
Time frame: up to 96 weeks
Determination of compliance of patient to treatment
Determination of compliance of patient to treatment
Time frame: up to 96 weeks
Proportion of patients having a viral load <50 copies/mlL at 96 weeks in the ITT (M=F) population;
Proportion of patients having a viral load \<50 copies/mlL at 96 weeks in the ITT (M=F) population
Time frame: up to 96 weeks
Proportion of patients with a virl load <50 copies/mL at 96 weeks (per protocol population)
Proportion of patients with a viral load \<50 copies/mL at 96 weeks (per protocol population)
Time frame: up to 96 weeks
Proportion of patients with a viral load <5 copies/mL at 96 weeks
Proportion of patients with a viral load \<5 copies/mL at 96 weeks
Time frame: up to 96 weeks
Change from baseline in CD4 counts at 24, 48, 96 weeks; Genotypic resistance profile of the HIV-1 in the event of virological failure CV >1000 copies/mL, as confirmed twice; Time to virologic failure (by Kaplan - Meier)
Change from baseline in CD4 counts at 24, 48, 96 weeks; Genotypic resistance profile of the HIV-1 in the event of virological failure CV \>1000 copies/mL, as confirmed twice; Time to virologic failure (by Kaplan - Meier)
Time frame: 24, 48, 96 weeks
Patient adherence (using the PMAQ3 instrument); Retrospective determination of HLAB57 as a marker for hypersensitivity reaction in patients randomized to the Trizivir arm.
Patient adherence (using the PMAQ3 instrument); Retrospective determination of HLAB57 as a marker for hypersensitivity reaction in patients randomized to the Trizivir arm.
Time frame: up to 96 weeks
Quantitative measurement of the residual replicative capacity (using cell-based assay) using number of quiescent cells and quantification of proviral DNA.
Quantitative measurement of the residual replicative capacity (using cell-based assay) using number of quiescent cells and quantification of proviral DNA.
Time frame: up to 96 weeks
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