Clinical Trial Results:
A Phase IIB, Randomized, Multicenter, Parallel Group Study to Evaluate the Short-Term Safety, Pharmacokinetics and Antiviral Activity of Four Blinded Dosing Regimens of GW640385/Ritonavir Therapy Compared to Open-label Current Protease Inhibitor (PI) therapy in HIV-1 Infected, PI Experienced Adults for 2 weeks with Long-Term Evaluation (> 48 weeks) of Safety, Pharmacokinetic and Antiviral Activity of Selected GW640385/RTV Dosing Regimen(s) vs. a Ritonavir-boosted, PI Containing Regimen
Summary
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EudraCT number |
2005-001150-24 |
Trial protocol |
GB DE IT PT |
Global completion date |
28 Jun 2007
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Nov 2016
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First version publication date |
16 Nov 2016
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Other versions |
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Summary report(s) |
gsk-hpr20001-synopsis-redact |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.