Activity of the soft gelatin formulation of saquinavir in combination therapy in antiretroviral-naive patients
| Autor: | Paul R. Skolnik, Ronald T. Mitsuyasu, Michael Gill, P C Jensen, Ramon A. Torres, J J Pulvirenti, L N Slater, S R Cohen, Melanie A. Thompson, Brian Conway, Robert T. Schooley, Christos M. Tsoukas |
|---|---|
| Rok vydání: | 1998 |
| Předmět: |
medicine.medical_specialty
education.field_of_study Chemotherapy Combination therapy business.industry medicine.medical_treatment Immunology Population Area under the curve Gastroenterology Surgery law.invention Infectious Diseases Pharmacotherapy Randomized controlled trial law Internal medicine medicine Immunology and Allergy education Adverse effect business Saquinavir medicine.drug |
| Zdroj: | AIDS. 12:F103-F109 |
| ISSN: | 0269-9370 |
| Popis: | OBJECTIVE A Phase II, open-label, randomized, parallel-arm, multicentre trial to compare the antiviral activity and safety of two formulations of saquinavir (SQV), soft gelatin (SQV-SGC) and hard gelatin (SQV-HGC) capsules, in combination with two nucleoside reverse transcriptase inhibitors (NRTI), in antiretroviral-naive, HIV-1-infected individuals. PARTICIPANTS A total of 171 people of > or = 13 years, with plasma HIV-1 RNA levels > or = 5000 copies/ml, who had received no protease inhibitor therapy, < or = 4 weeks NRTI therapy and no antiretroviral treatment within 28 days of screening. Eighty-one people were randomized to the SQV-HGC group and 90 to the SQV-SGC group. A total of 148 patients completed 16 weeks of therapy. INTERVENTION Therapy for 16 weeks with either SQV-SGC 1200 mg or SQV-HGC 600 mg, both three times a day, in combination with two NRTI. RESULTS Using an on-treatment analysis, patients taking SQV-SGC had a larger reduction in plasma HIV-1 RNA than those taking SQV-HGC (-2.0 versus -1.6 log10 copies/ml). Eighty per cent of those on SQV-SGC had < 400 copies HIV RNA/ml, compared with 43% in the SQV-HGC group (P = 0.001). A statistically significant difference in the area under the curve (AUC) values between the SQV-SGC and SQV-HGC arms (-1.7 versus -1.5 log10 copies/ml, respectively; P = 0.0054) was observed when withdrawals prior to week 12, major protocol violators and patients with < 75% compliance were excluded from the analysis; however, the difference between the values for the intent-to-treat population was not significant (P = 0.1929). Adverse events (mostly mild) included diarrhoea and nausea. CONCLUSIONS SQV-SGC was generally well tolerated and gave significantly more potent suppression of plasma HIV-1 RNA in antiretroviral-naive patients than SQVHGC. |
| Databáze: | OpenAIRE |
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