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.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- GlaxoSmithKline
- Enrollment
- 152
- Primary Endpoint
- Proportion of patients with a HIV plasma RNA<50 copies/ml at 48 weeks
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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\<50 copies/ml at 48 weeks
Secondary Outcomes
- Proportion of patients with a HIV plasma RNA <50copies/ml at 96 weeks.(up to 96 weeks)
- Genotypic profile resistance(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.(up to 96 weeks)
- Proportion of patients having a viral load <50 copies/mlL at 96 weeks in the ITT (M=F) population;(up to 96 weeks)
- CD4 count profile at baseline 24 W,48 and 96 W(24, 48, 96 weeks)
- Determination of compliance of patient to treatment(up to 96 weeks)
- Proportion of patients with a virl load <50 copies/mL at 96 weeks (per protocol population)(up to 96 weeks)
- Proportion of patients with a viral load <5 copies/mL at 96 weeks(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)(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.(up to 96 weeks)