The SPICE Study: 48-Week Activity of Combinations of Saquinavir Soft Gelatin and Nelfinavir With and Without Nucleoside Analogues
| Autor: | Graeme Moyle, Jolanda Pelgrom, Frank Duff, Anton Pozniak, Margaret A. Johnson, Patricia Delora, Jacques Reynes, Daniel Vittecoq, Milos Opravil, Miklos Salgo, Nathan Clumeck, Jean-François Delfraissy |
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| Rok vydání: | 2000 |
| Předmět: |
medicine.medical_specialty
business.industry Pharmacology Biology Gastroenterology Virology Nucleoside Reverse Transcriptase Inhibitor Infectious Diseases Pharmacotherapy Nelfinavir Internal medicine Multicenter trial Concomitant medicine Pharmacology (medical) Protease inhibitor (pharmacology) business Adverse effect Saquinavir Viral load medicine.drug |
| Zdroj: | Journal of Acquired Immune Deficiency Syndromes. 23:128-137 |
| ISSN: | 1525-4135 |
| DOI: | 10.1097/00042560-200002010-00004 |
| Popis: | OBJECTIVES To compare the efficacy and safety of saquinavir soft gelatin capsules (SQV-SGC) and nelfinavir (NFV), with or without two concomitant nucleoside reverse transcriptase inhibitors (NRTIs), in an exploratory objective to identify populations most likely to benefit from quadruple therapy. DESIGN Phase II/III, open-label, randomized, parallel-arm, multicenter trial. PARTICIPANTS Enrollment included 157 protease inhibitor-naive adults (> or = 13 years) with HIV-1 RNA > or = 10,000 copies/ml; 132 participants completed 48 weeks of therapy. INTERVENTIONS SQV-SGC 1200 mg, NFV 750 mg, SQV-SGC 800 mg plus NFV 750 mg, all with two NRTIs, and SQV-SGC 800 mg plus NFV 750 mg alone, all three times daily for 48 weeks. MAIN OUTCOME MEASURES Proportion of participants with HIV-1 RNA |
| Databáze: | OpenAIRE |
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