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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRIZIVIR | Drug | TRIZIVIR | ||
| Non-nucleoside reverse transcriptase inhibitor | Drug | Non-nucleoside reverse transcriptase inhibitor | ||
| Boosted Protease Inhibitor | Drug | Boosted Protease Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 96 weeks |
| CD4 count profile at baseline 24 W,48 and 96 W |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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CD4 count profile at baseline 24,48, and 96 weeks
| 24, 48, 96 weeks |
| Genotypic profile resistance | Genotypic profile resistance | up to 96 weeks |
| Determination of compliance of patient to treatment | Determination of compliance of patient to treatment | 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 | 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) | 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 | 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) | 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. | 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. | up to 96 weeks |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C418262 | abacavir, lamivudine, and zidovudine drug combination |
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