Study To Evaluate Long Term Maintenance With TRIZIVIR After Boosted Protease Inhibitor (PI) Or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) In HIV-1 Infected Adults

Phase 4

Completed

• Conditions: HIV Infections

• Registration Number: NCT00449436
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-10
• Study First Submitted: 2007-03-19
• Study First Submitted QC: 2007-03-19
• Study First Posted: 2007-03-20
• Primary Completion: 2007-12-12
• Study Completion: 2007-12-13
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a HIV plasma RNA<50 copies/ml at 48 weeks	48 weeks	Proportion of patients with a HIV plasma RNA\<50 copies/ml at 48 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with a HIV plasma RNA <50copies/ml at 96 weeks.	up to 96 weeks	Proportion of patients with a HIV plasma RNA \<50copies/ml at 96 weeks
Genotypic profile resistance	up to 96 weeks	Genotypic profile resistance
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	Quantitative measurement of the residual replicative capacity (using cell-based assay) using number of quiescent cells and quantification of proviral DNA.
Proportion of patients having a viral load <50 copies/mlL at 96 weeks in the ITT (M=F) population;	up to 96 weeks	Proportion of patients having a viral load \<50 copies/mlL at 96 weeks in the ITT (M=F) population
CD4 count profile at baseline 24 W,48 and 96 W	24, 48, 96 weeks	CD4 count profile at baseline 24,48, and 96 weeks
Determination of compliance of patient to treatment	up to 96 weeks	Determination of compliance of patient to treatment
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 \<50 copies/mL at 96 weeks (per protocol population)
Proportion of patients with a viral load <5 copies/mL at 96 weeks	up to 96 weeks	Proportion of patients with a viral load \<5 copies/mL at 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	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)
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	Patient adherence (using the PMAQ3 instrument); Retrospective determination of HLAB57 as a marker for hypersensitivity reaction in patients randomized to the Trizivir arm.