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| Descriptive Information Fields | |||||
| Brief Title † | Study to Explore Safety And Tolerability of Fosamprenavir With or Without Ritonavir in Combination With TRIZIVIR or COMBIVIR | ||||
| Official Title † | A Phase IIIb/IV, Randomized, Open Label, Multicenter, Pilot Trial to Explore the Safety and Tolerability of GW433908 +/- Ritonavir (1400mg Twice Daily or 700mg/100mg Twice Daily) When Used in Combination With a Zidovudine-Containing Regimen (TRIZIVIR or COMBIVIR Twice Daily) Over a 24 Week Period in Antiretroviral Therapy Naive HIV-1 Infected Subjects. | ||||
| Brief Summary | Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study to test the safety and tolerability of fosamprenavir with or without ritonavir in combination TRIZIVIR and COMBIVIR. Subjects will receive 24 weeks of therapy. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study | ||||
| Primary Outcome Measure † | To assess the overall short term tolerance of the regimens under investigation | ||||
| Secondary Outcome Measure † | Nature and incidence of laboratory abnormality; impact/burden of adverse events to subjects; plasma zidovudine (ZDV)pharmacokinetic parameters; change from baseline in plasma HIV-1 RNA levels over time. | ||||
| Condition † | HIV Infections | ||||
| Intervention † | Drug: fosamprenavir Drug: COMBIVIR Drug: ritonavir Drug: TRIZIVIR |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 60 | ||||
| Start Date † | January 2002 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 13 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, France, United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00043888 | ||||
| Organization ID | AZL30006 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | GlaxoSmithKline | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | March 2006 | ||||
| First Received Date † | August 14, 2002 | ||||
| Last Updated Date | March 6, 2006 | ||||