Trizivir
DrugTRIZIVIR
NCT Number: NCT00449436
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TRIZIVIR
Non-nucleoside reverse transcriptase inhibitor
Boosted Protease Inhibitor
Other names: TRIZIVIR, Non-nucleoside reverse transcriptase inhibitor
Time frame: 48 weeks
Proportion of patients with a HIV plasma RNA<50 copies/ml at 48 weeks
Time frame: up to 96 weeks
Proportion of patients with a HIV plasma RNA <50copies/ml at 96 weeks
Time frame: 24, 48, 96 weeks
CD4 count profile at baseline 24,48, and 96 weeks
Time frame: up to 96 weeks
Genotypic profile resistance
Time frame: up to 96 weeks
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
Time frame: up to 96 weeks
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
Time frame: 24, 48, 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)
Time frame: up to 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.
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.
GlaxoSmithKline
Industry
A Randomised, Open-Label Study to Evaluate the Efficacy and Safety of a Treatment Optimisation With Trizivir During 96 Weeks After a First Antiretroviral Treatment in HIV-1 Infected Subjects.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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