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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00450580 |
This is a Phase IIIB, 48 Week, multicentre, randomized, open-label, parallel group study comparing the safety and efficacy of fosamprenavir plus ritonavir 1400mg/100mg once-daily to fosamprenavir plus ritonavir 700mg/100mg twice-daily, both administered with abacavir/lamivudine 600mg/300mg once-daily in antiretroviral-naive HIV-1 infected adults. This study utilizes a group-sequential design with two stages: 1) an interim 24 week cohort analysis of approximately 200 subjects and 2) if study continuation criteria are met at this interim analysis, further enrolment of an additional 528 subjects, followed over a minimum of 48 weeks. The objectives of the study are to demonstrate 1) non-inferior antiviral activity of fosamprenavir/ritonavir 1400mg/100mg QD compared to fosamprenavir/ritonavir 700mg/100mg BID and 2) a superior fasting non-HDL lipid profile in subjects receiving fosamprenavir/ritonavir 1400mg/100mg QD.
Condition | Intervention | Phase |
---|---|---|
HIV-1 Infection |
Drug: fosamprenavir/ritonavir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study of Once-Daily Versus Twice-Daily Fosamprenavir Plus Ritonavir, Administered With Abacavir/Lamivudine Once-Daily in Antiretroviral-Naive HIV-1 Infected Adult Subjects. |
Estimated Enrollment: | 728 |
Study Start Date: | March 2007 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A female is eligible to enter and participate in the study if she is of:
Child-bearing potential, has a negative pregnancy test (serum b-HCG) at screen and agrees to one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the approved product label and the instructions of a physician):
Exclusion Criteria:
NOTE: Creatinine clearance should be estimated using the following formula:
For serum creatinine concentration in mg/dL:
For serum creatinine concentration in µmol/L:
HMG-CoA reductase inhibitors (statins), niacin, fibrates, bile acid sequestrants, and/or fish oil supplements. Subjects anticipated to require initiation of therapy with these agents within 12 weeks of Baseline are not eligible to participate.
Subjects who require treatment with any of the following medications within 28 days of commencement of investigational product, or an anticipated need during the study:
Subjects recruited at sites in France will be excluded if:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | APV109141, MERIT |
Study First Received: | March 21, 2007 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00450580 History of Changes |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Romania: National Medicines Agency; Spain: Ministry of Health and Consumption; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Italy: The Italian Medicines Agency |
HIV-1, Fosamprenavir, protease inhibitor, |
ritonavir, naive, non-HDL cholesterol |
HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Fosamprenavir Ritonavir HIV Infections |
Acquired Immunodeficiency Syndrome Lamivudine Abacavir Antiviral Agents Protease Inhibitors |
Communicable Diseases Anti-Infective Agents HIV Protease Inhibitors Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Protease Inhibitors Fosamprenavir Anti-Retroviral Agents Ritonavir Therapeutic Uses |