Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure - Tabular View

Tracking Information
First Received Date ^ICMJE	October 15, 2001
Last Updated Date	June 23, 2005
Start Date ^ICMJE	May 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00025727 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure
Official Title ^ICMJE	A Phase III, Randomized, Multicenter, Parallel Group, Open-Label, Three Arm Study to Compare the Efficacy and Safety of Two Dosing Regimens of GW433908/Ritonavir (700mg/100mg Twice Daily or 1400mg/200mg Once Daily) Versus Lopinavir/Ritonavir (400mg/100mg Twice Daily) for 48 Weeks in Protease Inhibitor Experienced HIV-Infected Adults Experiencing Virological Failure
Brief Summary	The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV) versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors (RTIs), in patients who have taken anti-HIV drugs without success.
Detailed Description	Patients will receive 2 dosing regimens of GW433908/RTV or LPV/RTV, in combination with 2 active RTIs, after failing their first or second protease inhibitor-containing regimen. Patients are required to be on therapy at time of screening and must remain on this therapy until Day 1.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Parallel Assignment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Lopinavir/Ritonavir Drug: Ritonavir Drug: GW433908
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	330
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Patients may be eligible for this study if they: Have a viral load of 1,000 or more copies/ml. Have taken protease inhibitors (PIs). Have taken PI drugs for at least 12 straight weeks and have had virologic failure on the PIs. Are now taking antiretroviral therapy. Are male or female and are at least 13 years old (or 18 if local requirement) and can provide consent from parent or guardian if under 18. Are females unable to have children or, if are able to have children, are not pregnant and agree to use approved birth control. Exclusion Criteria Patients will not be eligible for this study if they: Have taken APV or LPV for more than 1 week. Have taken tenofovir disoproxil fumarate (TDF) or adefovir. Have taken more than 2 PIs. Are unable to take 2 active RTIs, as specified by the study. Have an active CDC Category C disease. Have certain abnormal laboratory tests. Are pregnant or breast-feeding. Have a serious health problem (e.g., diabetes, heart problems, hepatitis) that might risk the safety of the patient. Have a history of significant kidney or bone disease. Are not able to take drugs by mouth and cannot absorb them. Have had pancreatitis or hepatitis within the previous 6 months. Have a drug allergy or other allergy which might cause a problem during the study. Have had radiation or chemotherapy within 28 days of taking the study drug, or expect to need these during the study. Have taken drugs that affect the immune system (corticosteroids, interleukins, interferons) or drugs with anti-HIV activity (hydroxyurea or foscarnet) within 28 days prior to taking the study drug. Have had any HIV vaccine within 3 months before taking the study drug. Have taken certain other drugs within 28 days prior to taking the study drug, or expect to need them during the study. Use alcohol or illicit drugs in a way that the doctor feels would interfere with the study. Are not able to take the study drugs. Have inadequate kidney function.
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00025727
Responsible Party
Study ID Numbers ^ICMJE	316C
Study Sponsor ^ICMJE	GlaxoSmithKline
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	June 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP