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Substitution with lopinavir/ritonavir improves patient-reported outcomes including quality of life in patients who were intolerant to their antiretroviral therapy.
Sprinz, Eduardo; Neto, Andrade J; Bargman, Eduardo; Green, Stephen L; Luo, Michelle P; Sylte, Jacquelyn R; McMillan, Florence I; King, Kathryn R; Rode, Richard A; Brun, Scott C; Hanna, George J; Podsadecki, Thomas J.
Afiliação
  • Sprinz E; Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Brazil.
HIV Clin Trials ; 7(6): 291-308, 2006.
Article em En | MEDLINE | ID: mdl-17197377
PURPOSE: Adverse effects are important determinants of quality of life (QOL) during highly active antiretroviral therapy (HAART). The PLATO study investigated the association between changes in patient-reported outcomes including QOL and substitution with lopinavir/ritonavir in patients experiencing side effects (SEs). METHOD: HIV-1-infected participants (N = 849) with undetectable viral load experiencing Grade-2 SEs of the protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) component of their HAART regimen were randomized to immediate (baseline) or deferred (week 4) substitution with lopinavir/ritonavir soft-gel capsules 400/100 mg bid. The primary endpoint was change in the total score from the AIDS Clinical Trials Group (ACTG) Symptoms Distress Module (ASDM), supplemented with two items for nephrolithiasis. Secondary endpoints included Medical Outcomes Study (MOS)-HIV scores and Center for Epidemiologic Studies-Depression (CES-D) scores. RESULTS: Immediate substitution resulted in improved ASDM total score at week 4 compared with deferred substitution (p <.001) and significant improvements in all MOS-HIV domains, while significant improvement was observed in CES-D scores at week 8. Primary SEs resolved at week 8 in 65% of participants in the immediate substitution group. Suppression of HIV-1 was maintained. Treatment was well-tolerated and associated with elevations in cholesterol and triglycerides. CONCLUSION: Substitution with LPV/r improved patient-reported outcomes including QOL in patients experiencing Grade-2 SEs, while maintaining viral suppression.
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Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pirimidinonas / Infecções por HIV / Ritonavir / Terapia Antirretroviral de Alta Atividade Tipo de estudo: Clinical_trials / Observational_studies / Risk_factors_studies Aspecto: Patient_preference Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: HIV Clin Trials Assunto da revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) / TERAPEUTICA Ano de publicação: 2006 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido
Buscar no Google
Adicionar na Minha BVS
Imprimir
XML
PubMed Links

Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pirimidinonas / Infecções por HIV / Ritonavir / Terapia Antirretroviral de Alta Atividade Tipo de estudo: Clinical_trials / Observational_studies / Risk_factors_studies Aspecto: Patient_preference Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: HIV Clin Trials Assunto da revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) / TERAPEUTICA Ano de publicação: 2006 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido