Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Activity of the soft gelatin formulation of saquinavir in combination therapy in antiretroviral-naive patients. NV15355 Study Team.
AIDS. 1998 Jul 30;12(11):F103-9. Unique Identifier : AIDSLINE MED/98372104 Mitsuyasu RT; Skolnik PR; Cohen SR; Conway B; Gill MJ; Jensen PC; Pulvirenti JJ; Slater LN; Schooley RT; Thompson MA; Torres RA; Tsoukas CM; University of California, Los Angeles, USA.
Abstract:
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.
Keywords: CLINICAL TRIAL CLINICAL TRIAL, PHASE II JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL Adolescence Adult Anti-HIV Agents/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Chemistry, Pharmaceutical Comparative Study Consumer Product Safety CD4 Lymphocyte Count Drug Therapy, Combination Female *Gelatin Human HIV Infections/*DRUG THERAPY/IMMUNOLOGY/VIROLOGY HIV Protease Inhibitors/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE *HIV-1/GENETICS Male Middle Age RNA, Viral/BLOOD Saquinavir/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Support, Non-U.S. Gov't 990130
A9911074
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Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
