AustralieFrV1, Ncbi, Curation, bibRecord, 002302

Raltegravir Non-Inferior to Nucleoside Based Regimens in SECOND-LINE Therapy with Lopinavir/Ritonavir over 96 Weeks: A Randomised Open Label Study for the Treatment Of HIV-1 Infection

Identifieur interne : 002302 ( Ncbi/Curation ); précédent : 002301; suivant : 002303

Raltegravir Non-Inferior to Nucleoside Based Regimens in SECOND-LINE Therapy with Lopinavir/Ritonavir over 96 Weeks: A Randomised Open Label Study for the Treatment Of HIV-1 Infection

Auteurs : Janaki Amin [Australie] ; Mark A. Boyd [Australie] ; Nagalingeswaran Kumarasamy [Inde] ; Cecilia L. Moore [Australie] ; Marcello H. Losso [Argentine] ; Chidi A. Nwizu [États-Unis] ; Lerato Mohapi [Afrique du Sud] ; Stephen J. Kerr [Thaïlande] ; Annette H. Sohn [Thaïlande] ; Hedy Teppler [États-Unis] ; Boris Renjifo [États-Unis] ; Jean-Michel Molina [France] ; Sean Emery [Australie] ; David A. Cooper [Australie]

Source :

PLoS ONE [ 1932-6203 ] ; 2015.

RBID : PMC:4344344

Descripteurs français

English descriptors

KwdEn :
- Adult, Drug Therapy, Combination, HIV Infections (drug therapy), HIV Integrase Inhibitors (administration & dosage), HIV Integrase Inhibitors (adverse effects), HIV Integrase Inhibitors (therapeutic use), HIV Protease Inhibitors (administration & dosage), HIV Protease Inhibitors (adverse effects), HIV Protease Inhibitors (therapeutic use), HIV-1, Humans, Lopinavir (administration & dosage), Lopinavir (adverse effects), Lopinavir (therapeutic use), Male, Raltegravir Potassium (administration & dosage), Raltegravir Potassium (adverse effects), Raltegravir Potassium (therapeutic use), Ritonavir (administration & dosage), Ritonavir (adverse effects), Ritonavir (therapeutic use), Secondary Care.
MESH :
- chemical , administration & dosage : HIV Integrase Inhibitors, HIV Protease Inhibitors, Lopinavir, Raltegravir Potassium, Ritonavir.
- chemical , adverse effects : HIV Integrase Inhibitors, HIV Protease Inhibitors, Lopinavir, Raltegravir Potassium, Ritonavir.
- drug therapy : HIV Infections.
- chemical , therapeutic use : HIV Integrase Inhibitors, HIV Protease Inhibitors, Lopinavir, Raltegravir Potassium, Ritonavir.
- Adult, Drug Therapy, Combination, HIV-1, Humans, Male, Secondary Care.

Abstract

Objective

To determine the durability over 96 weeks of safety and efficacy of lopinavir/ritonavir (LPV/r) and raltegravir (RAL) which was demonstrated to have non-inferior efficacy relative to a regimen of LPV/r with nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTIs) (Control) in primary analysis at 48 weeks.

Design

Open label, centrally randomised trial.

Setting

Recruitment was from 37 primary and secondary care sites from Africa, Asia, Australia, Europe and Latin America.

Subjects

541 HIV-1 infected adults virologically failing first-line non-NRTI + 2N(t)RTI, with no previous exposure to protease inhibitors or integrase strand transfer inhibitors were analysed, 425 completed 96 weeks follow up on randomised therapy.

Intervention

Randomisation was 1:1 to Control or RAL.

Main outcome measures

Differences between the proportion of participants with plasma HIV-1 RNA (VL) <200 copies/mL by intention to treat were compared with a non-inferiority margin of −12%. Differences in biochemical, haematological and metabolic changes were assessed using T-tests.

Results

VL <200 copies/mL at 96 weeks was: RAL 80.4%, Control 76.0% (difference: 4.4 [95%CI −2.6, 11.3]) and met non-inferiority criteria. The RAL arm had a significantly higher mean change (difference Control-RAL; 95%CI) in haemoglobin (−2.9; −5.7, −1.1), total lymphocytes (−0.2; −0.3, −0.0), total cholesterol (−0.5; −0.8, −0.3), HDL cholesterol (−0.1; −0.1, −0.0) and LDL cholesterol (−0.3; −0.5, −0.2).

Conclusion

At 96 weeks, both RAL and Control maintained efficacy greater than 75% and continued to demonstrate similar safety profiles. These results support the use of a combination LPV/r and RAL regimen as an option following failure of 1st line NNRTI + 2N(t)RTIs.

Trial Registration

ClinicalTrials.gov NCT00931463

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4344344

DOI: 10.1371/journal.pone.0118228
PubMed: 25723472
PubMed Central: 4344344

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PMC:4344344

Le document en format XML

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<term>Drug Therapy, Combination</term>
<term>HIV Infections (drug therapy)</term>
<term>HIV Integrase Inhibitors (administration & dosage)</term>
<term>HIV Integrase Inhibitors (adverse effects)</term>
<term>HIV Integrase Inhibitors (therapeutic use)</term>
<term>HIV Protease Inhibitors (administration & dosage)</term>
<term>HIV Protease Inhibitors (adverse effects)</term>
<term>HIV Protease Inhibitors (therapeutic use)</term>
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<term>Lopinavir (adverse effects)</term>
<term>Lopinavir (therapeutic use)</term>
<term>Male</term>
<term>Raltegravir Potassium (administration & dosage)</term>
<term>Raltegravir Potassium (adverse effects)</term>
<term>Raltegravir Potassium (therapeutic use)</term>
<term>Ritonavir (administration & dosage)</term>
<term>Ritonavir (adverse effects)</term>
<term>Ritonavir (therapeutic use)</term>
<term>Secondary Care</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term>
<term>Association de médicaments</term>
<term>Humains</term>
<term>Infections à VIH (traitement médicamenteux)</term>
<term>Inhibiteurs de l'intégrase du VIH (administration et posologie)</term>
<term>Inhibiteurs de l'intégrase du VIH (effets indésirables)</term>
<term>Inhibiteurs de l'intégrase du VIH (usage thérapeutique)</term>
<term>Inhibiteurs de protéase du VIH (administration et posologie)</term>
<term>Inhibiteurs de protéase du VIH (effets indésirables)</term>
<term>Inhibiteurs de protéase du VIH (usage thérapeutique)</term>
<term>Lopinavir (administration et posologie)</term>
<term>Lopinavir (effets indésirables)</term>
<term>Lopinavir (usage thérapeutique)</term>
<term>Mâle</term>
<term>Raltégravir de potassium (administration et posologie)</term>
<term>Raltégravir de potassium (effets indésirables)</term>
<term>Raltégravir de potassium (usage thérapeutique)</term>
<term>Ritonavir (administration et posologie)</term>
<term>Ritonavir (effets indésirables)</term>
<term>Ritonavir (usage thérapeutique)</term>
<term>Soins secondaires</term>
<term>VIH-1 (Virus de l'Immunodéficience Humaine de type 1)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>HIV Integrase Inhibitors</term>
<term>HIV Protease Inhibitors</term>
<term>Lopinavir</term>
<term>Raltegravir Potassium</term>
<term>Ritonavir</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>HIV Integrase Inhibitors</term>
<term>HIV Protease Inhibitors</term>
<term>Lopinavir</term>
<term>Raltegravir Potassium</term>
<term>Ritonavir</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Inhibiteurs de l'intégrase du VIH</term>
<term>Inhibiteurs de protéase du VIH</term>
<term>Lopinavir</term>
<term>Raltégravir de potassium</term>
<term>Ritonavir</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>HIV Infections</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Inhibiteurs de l'intégrase du VIH</term>
<term>Inhibiteurs de protéase du VIH</term>
<term>Lopinavir</term>
<term>Raltégravir de potassium</term>
<term>Ritonavir</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>HIV Integrase Inhibitors</term>
<term>HIV Protease Inhibitors</term>
<term>Lopinavir</term>
<term>Raltegravir Potassium</term>
<term>Ritonavir</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Infections à VIH</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Inhibiteurs de l'intégrase du VIH</term>
<term>Inhibiteurs de protéase du VIH</term>
<term>Lopinavir</term>
<term>Raltégravir de potassium</term>
<term>Ritonavir</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Drug Therapy, Combination</term>
<term>HIV-1</term>
<term>Humans</term>
<term>Male</term>
<term>Secondary Care</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Association de médicaments</term>
<term>Humains</term>
<term>Mâle</term>
<term>Soins secondaires</term>
<term>VIH-1 (Virus de l'Immunodéficience Humaine de type 1)</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec id="sec001"><title>Objective</title>
<p>To determine the durability over 96 weeks of safety and efficacy of lopinavir/ritonavir (LPV/r) and raltegravir (RAL) which was demonstrated to have non-inferior efficacy relative to a regimen of LPV/r with nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTIs) (Control) in primary analysis at 48 weeks.</p>
</sec>
<sec id="sec002"><title>Design</title>
<p>Open label, centrally randomised trial.</p>
</sec>
<sec id="sec003"><title>Setting</title>
<p>Recruitment was from 37 primary and secondary care sites from Africa, Asia, Australia, Europe and Latin America.</p>
</sec>
<sec id="sec004"><title>Subjects</title>
<p>541 HIV-1 infected adults virologically failing first-line non-NRTI + 2N(t)RTI, with no previous exposure to protease inhibitors or integrase strand transfer inhibitors were analysed, 425 completed 96 weeks follow up on randomised therapy.</p>
</sec>
<sec id="sec005"><title>Intervention</title>
<p>Randomisation was 1:1 to Control or RAL.</p>
</sec>
<sec id="sec006"><title>Main outcome measures</title>
<p>Differences between the proportion of participants with plasma HIV-1 RNA (VL) <200 copies/mL by intention to treat were compared with a non-inferiority margin of −12%. Differences in biochemical, haematological and metabolic changes were assessed using T-tests.</p>
</sec>
<sec id="sec007"><title>Results</title>
<p>VL <200 copies/mL at 96 weeks was: RAL 80.4%, Control 76.0% (difference: 4.4 [95%CI −2.6, 11.3]) and met non-inferiority criteria. The RAL arm had a significantly higher mean change (difference Control-RAL; 95%CI) in haemoglobin (−2.9; −5.7, −1.1), total lymphocytes (−0.2; −0.3, −0.0), total cholesterol (−0.5; −0.8, −0.3), HDL cholesterol (−0.1; −0.1, −0.0) and LDL cholesterol (−0.3; −0.5, −0.2).</p>
</sec>
<sec id="sec008"><title>Conclusion</title>
<p>At 96 weeks, both RAL and Control maintained efficacy greater than 75% and continued to demonstrate similar safety profiles. These results support the use of a combination LPV/r and RAL regimen as an option following failure of 1st line NNRTI + 2N(t)RTIs.</p>
</sec>
<sec id="sec009"><title>Trial Registration</title>
<p>ClinicalTrials.gov <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00931463">NCT00931463</ext-link>
</p>
</sec>
</div>
</front>
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Raltegravir Non-Inferior to Nucleoside Based Regimens in SECOND-LINE Therapy with Lopinavir/Ritonavir over 96 Weeks: A Randomised Open Label Study for the Treatment Of HIV-1 Infection

Raltegravir Non-Inferior to Nucleoside Based Regimens in SECOND-LINE Therapy with Lopinavir/Ritonavir over 96 Weeks: A Randomised Open Label Study for the Treatment Of HIV-1 Infection

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