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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01009814 |
Purpose
Research Hypothesis: Administration of BMS-663068, a prodrug for BMS-626529, will result in a mean decrease of at least 1 log10 in HIV RNA at Day 9 following 8 days of therapy in at least one dosing regimen that is safe and well tolerated in Clade B HIV-1 infected subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 Infections |
Drug: BMS-663068 with or without ritonavir |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized, Open Label, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of BMS-663068 in HIV-1 Infected Subjects |
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1: Experimental
BMS-663068 and ritonavir
|
Drug: BMS-663068 with or without ritonavir
8-day treatment with BMS-663068 with or without ritonavir Group 1: BMS-663068 600 mg Q12H + ritonavir 100 mg Q12H Group 2: BMS-663068 1200 mg QHS + ritonavir 100 mg QHS Group 3: BMS-663068 1200 mg Q12H + ritonavir100 mg Q12H Group 4: BMS-663068 1200 mg Q12H + ritonavir 100 mg QAM Group 5: BMS-663068 1200 mg Q12H |
|
Group 2: Experimental
BMS-663068 and ritonavir
|
Drug: BMS-663068 with or without ritonavir
8-day treatment with BMS-663068 with or without ritonavir Group 1: BMS-663068 600 mg Q12H + ritonavir 100 mg Q12H Group 2: BMS-663068 1200 mg QHS + ritonavir 100 mg QHS Group 3: BMS-663068 1200 mg Q12H + ritonavir100 mg Q12H Group 4: BMS-663068 1200 mg Q12H + ritonavir 100 mg QAM Group 5: BMS-663068 1200 mg Q12H |
|
Group 3: Experimental
BMS-663068 and ritonavir
|
Drug: BMS-663068 with or without ritonavir
8-day treatment with BMS-663068 with or without ritonavir Group 1: BMS-663068 600 mg Q12H + ritonavir 100 mg Q12H Group 2: BMS-663068 1200 mg QHS + ritonavir 100 mg QHS Group 3: BMS-663068 1200 mg Q12H + ritonavir100 mg Q12H Group 4: BMS-663068 1200 mg Q12H + ritonavir 100 mg QAM Group 5: BMS-663068 1200 mg Q12H |
|
Group 4: Experimental
BMS-663068 and ritonavir
|
Drug: BMS-663068 with or without ritonavir
8-day treatment with BMS-663068 with or without ritonavir Group 1: BMS-663068 600 mg Q12H + ritonavir 100 mg Q12H Group 2: BMS-663068 1200 mg QHS + ritonavir 100 mg QHS Group 3: BMS-663068 1200 mg Q12H + ritonavir100 mg Q12H Group 4: BMS-663068 1200 mg Q12H + ritonavir 100 mg QAM Group 5: BMS-663068 1200 mg Q12H |
|
Group 5: Experimental
BMS-663068
|
Drug: BMS-663068 with or without ritonavir
8-day treatment with BMS-663068 with or without ritonavir Group 1: BMS-663068 600 mg Q12H + ritonavir 100 mg Q12H Group 2: BMS-663068 1200 mg QHS + ritonavir 100 mg QHS Group 3: BMS-663068 1200 mg Q12H + ritonavir100 mg Q12H Group 4: BMS-663068 1200 mg Q12H + ritonavir 100 mg QAM Group 5: BMS-663068 1200 mg Q12H |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clade B HIV-1 infected subjects meeting following criteria at screening:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Local Institution | Recruiting |
| Berlin, Germany | |
| Contact: Site 01 be.life.be.80.1090387@sgs.com | |
| Poland | |
| Local institution | Not yet recruiting |
| Bydgoszcz, Poland | |
| Contact be.life.be.80.1090387@sgs.com | |
| Local institution | Not yet recruiting |
| Warsaw, Poland | |
| Contact be.life.be.80.1090387@sgs.com | |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| Responsible Party: | Bristol Myers Squibb ( Study Director ) |
| Study ID Numbers: | AI438-006 |
| Study First Received: | November 6, 2009 |
| Last Updated: | December 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT01009814 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
|
HIV |
|
Anti-Infective Agents HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Ritonavir |
Therapeutic Uses Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors |