AustralieFrV1, Main, Exploration, bibRecord, 009F94

Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the randomized evaluation of strategic intervention in multi-drug resistant patients with tipranavir (RESIST) studies : an analysis of combined data from two randomised open-label trials

Identifieur interne : 009F94 ( Main/Exploration ); précédent : 009F93; suivant : 009F95

Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the randomized evaluation of strategic intervention in multi-drug resistant patients with tipranavir (RESIST) studies : an analysis of combined data from two randomised open-label trials

Auteurs : Charles B. Hicks [États-Unis] ; Pedro Cahn [Argentine] ; David A. Cooper [Australie] ; Sharon L. Walmsley [Canada] ; Christine Katlama [France] ; Bonaventura Clotet [Espagne] ; Adriano Lazzarin [Italie] ; Margaret A. Johnson [Royaume-Uni] ; Dietmar Neubacher [Allemagne] ; Douglas Mayers [États-Unis] ; Hernan Valdez [États-Unis]

Source :

Lancet : (British edition) [ 0140-6736 ] ; 2006.

RBID : Pascal:06-0376302

Descripteurs français

Pascal (Inist)
- Ritonavir, Tipranavir, Association médicamenteuse, SIDA, Sevrage toxique, Randomisation, Chimiothérapie, Evaluation, Stratégie, Traitement, Résistance multiple, Homme, Malade, Analyse donnée, Essai clinique, Médicament, Médecine, Antiviral, Antirétroviral, Essai thérapeutique, Essai ouvert.
Wicri :
- topic : Homme, Médicament, Médecine.

English descriptors

KwdEn :
- AIDS, Antiretroviral agent, Antiviral, Chemotherapy, Clinical trial, Data analysis, Drug, Drug combination, Evaluation, Human, Medicine, Multiple resistance, Patient, Poison withdrawal, Randomization, Ritonavir, Strategy, Tipranavir, Treatment.

Abstract

Background Treatment options for HIV-1 infected individuals who have received extensive previous antiretroviral therapy are limited. We compared efficacy and safety of the novel non-peptidic protease inhibitor tipranavir co-administered with ritonavir plus an optimised background regimen with that of an investigator-selected ritonavir-boosted comparator protease inhibitor (CPI-ritonavir) in such patients. Methods We did a combined analysis of 48-week data from two ongoing, randomised, open-label, multinational, phase III, RESIST studies. HIV-1-infected adults with 3 months or longer previous triple antiretroviral class experience, two or more previous protease inhibitor regimens, HIV-1 RNA 1000 copies per mL or greater, and genotypically demonstrated primary resistance to protease inhibitor, were eligible. Primary endpoints were proportion of treatment responders (with reduction in viral load of 1 log₁₀ copies per mL or greater below baseline without treatment change) at 48 weeks and time to treatment failure through 48 weeks (intention-to-treat analysis). The RESIST studies are registered with ClinicalTrials.gov, numbers NCT00054717 (RESIST-1) and NCT00144170 (RESIST-2). Findings 3324 patients were screened; 746 received tipranavir-ritonavir and 737 CPI-ritonavir. 486 (65.1%) patients on tipranavir-ritonavir and 192 (26.1%) on CPI-ritonavir remained on assigned treatment until week 48. At week 48, more patients achieved and maintained treatment response in the tipranavir-ritonavir group than in the CPI-ritonavir group (251 [33-6%] vs 113 [15-3%]; p<0-0001). Median time to treatment failure was significantly longer in the tipranavir-ritonavir group than in the CPI-ritonavir group (113 days vs 0 days; p<0-0001). Gastrointestinal system disorders and raised transaminase, cholesterol, and triglycerides were more frequent in the tipranavir-ritonavir group than in the CPI-ritonavir group. Interpretation Compared with CPI-ritonavir, tipranavir-ritonavir with an optimised background regimen provides better virological and immunological responses over 48 weeks in patients who have received extensive previous antiretroviral treatment.

Affiliations:

Allemagne, Argentine, Australie, Canada, Espagne, France, Italie, Royaume-Uni, États-Unis
Angleterre, Catalogne, Grand Londres, Lombardie, Ontario, Île-de-France
Barcelone, Londres, Milan, Paris, Toronto
Université de Toronto

Links toward previous steps (curation, corpus...)

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Le document en format XML

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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>AIDS</term>
<term>Antiretroviral agent</term>
<term>Antiviral</term>
<term>Chemotherapy</term>
<term>Clinical trial</term>
<term>Data analysis</term>
<term>Drug</term>
<term>Drug combination</term>
<term>Evaluation</term>
<term>Human</term>
<term>Medicine</term>
<term>Multiple resistance</term>
<term>Patient</term>
<term>Poison withdrawal</term>
<term>Randomization</term>
<term>Ritonavir</term>
<term>Strategy</term>
<term>Tipranavir</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Ritonavir</term>
<term>Tipranavir</term>
<term>Association médicamenteuse</term>
<term>SIDA</term>
<term>Sevrage toxique</term>
<term>Randomisation</term>
<term>Chimiothérapie</term>
<term>Evaluation</term>
<term>Stratégie</term>
<term>Traitement</term>
<term>Résistance multiple</term>
<term>Homme</term>
<term>Malade</term>
<term>Analyse donnée</term>
<term>Essai clinique</term>
<term>Médicament</term>
<term>Médecine</term>
<term>Antiviral</term>
<term>Antirétroviral</term>
<term>Essai thérapeutique</term>
<term>Essai ouvert</term>
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<front><div type="abstract" xml:lang="en">Background Treatment options for HIV-1 infected individuals who have received extensive previous antiretroviral therapy are limited. We compared efficacy and safety of the novel non-peptidic protease inhibitor tipranavir co-administered with ritonavir plus an optimised background regimen with that of an investigator-selected ritonavir-boosted comparator protease inhibitor (CPI-ritonavir) in such patients. Methods We did a combined analysis of 48-week data from two ongoing, randomised, open-label, multinational, phase III, RESIST studies. HIV-1-infected adults with 3 months or longer previous triple antiretroviral class experience, two or more previous protease inhibitor regimens, HIV-1 RNA 1000 copies per mL or greater, and genotypically demonstrated primary resistance to protease inhibitor, were eligible. Primary endpoints were proportion of treatment responders (with reduction in viral load of 1 log<sub>10</sub>
 copies per mL or greater below baseline without treatment change) at 48 weeks and time to treatment failure through 48 weeks (intention-to-treat analysis). The RESIST studies are registered with ClinicalTrials.gov, numbers NCT00054717 (RESIST-1) and NCT00144170 (RESIST-2). Findings 3324 patients were screened; 746 received tipranavir-ritonavir and 737 CPI-ritonavir. 486 (65.1%) patients on tipranavir-ritonavir and 192 (26.1%) on CPI-ritonavir remained on assigned treatment until week 48. At week 48, more patients achieved and maintained treatment response in the tipranavir-ritonavir group than in the CPI-ritonavir group (251 [33-6%] vs 113 [15-3%]; p<0-0001). Median time to treatment failure was significantly longer in the tipranavir-ritonavir group than in the CPI-ritonavir group (113 days vs 0 days; p<0-0001). Gastrointestinal system disorders and raised transaminase, cholesterol, and triglycerides were more frequent in the tipranavir-ritonavir group than in the CPI-ritonavir group. Interpretation Compared with CPI-ritonavir, tipranavir-ritonavir with an optimised background regimen provides better virological and immunological responses over 48 weeks in patients who have received extensive previous antiretroviral treatment.</div>
</front>
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<li>Argentine</li>
<li>Australie</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Italie</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Catalogne</li>
<li>Grand Londres</li>
<li>Lombardie</li>
<li>Ontario</li>
<li>Île-de-France</li>
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<settlement><li>Barcelone</li>
<li>Londres</li>
<li>Milan</li>
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<tree><country name="États-Unis"><noRegion><name sortKey="Hicks, Charles B" sort="Hicks, Charles B" uniqKey="Hicks C" first="Charles B." last="Hicks">Charles B. Hicks</name>
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<name sortKey="Mayers, Douglas" sort="Mayers, Douglas" uniqKey="Mayers D" first="Douglas" last="Mayers">Douglas Mayers</name>
<name sortKey="Valdez, Hernan" sort="Valdez, Hernan" uniqKey="Valdez H" first="Hernan" last="Valdez">Hernan Valdez</name>
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<country name="Argentine"><noRegion><name sortKey="Cahn, Pedro" sort="Cahn, Pedro" uniqKey="Cahn P" first="Pedro" last="Cahn">Pedro Cahn</name>
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<country name="Australie"><noRegion><name sortKey="Cooper, David A" sort="Cooper, David A" uniqKey="Cooper D" first="David A." last="Cooper">David A. Cooper</name>
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</country>
<country name="Canada"><region name="Ontario"><name sortKey="Walmsley, Sharon L" sort="Walmsley, Sharon L" uniqKey="Walmsley S" first="Sharon L." last="Walmsley">Sharon L. Walmsley</name>
</region>
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<country name="France"><region name="Île-de-France"><name sortKey="Katlama, Christine" sort="Katlama, Christine" uniqKey="Katlama C" first="Christine" last="Katlama">Christine Katlama</name>
</region>
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<country name="Espagne"><region name="Catalogne"><name sortKey="Clotet, Bonaventura" sort="Clotet, Bonaventura" uniqKey="Clotet B" first="Bonaventura" last="Clotet">Bonaventura Clotet</name>
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</country>
<country name="Italie"><region name="Lombardie"><name sortKey="Lazzarin, Adriano" sort="Lazzarin, Adriano" uniqKey="Lazzarin A" first="Adriano" last="Lazzarin">Adriano Lazzarin</name>
</region>
</country>
<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Johnson, Margaret A" sort="Johnson, Margaret A" uniqKey="Johnson M" first="Margaret A." last="Johnson">Margaret A. Johnson</name>
</region>
</country>
<country name="Allemagne"><noRegion><name sortKey="Neubacher, Dietmar" sort="Neubacher, Dietmar" uniqKey="Neubacher D" first="Dietmar" last="Neubacher">Dietmar Neubacher</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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   |texte=   Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the randomized evaluation of strategic intervention in multi-drug resistant patients with tipranavir (RESIST) studies : an analysis of combined data from two randomised open-label trials
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Data generation: Tue Dec 5 10:43:12 2017. Site generation: Tue Mar 5 14:07:20 2024

	Serveur d'exploration sur les relations entre la France et l'Australie
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Serveur d'exploration sur les relations entre la France et l'Australie