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
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
1 other identifier
interventional
330
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 15, 2001
CompletedFirst Posted
Study publicly available on registry
October 16, 2001
CompletedJune 24, 2005
June 1, 2002
October 15, 2001
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (32)
Phoenix Body Positive
Phoenix, Arizona, 85006, United States
Ocean View Internal Medicine
Long Beach, California, 90803, United States
Bisher Akil
Los Angeles, California, 90046, United States
Tower ID Med Associates
Los Angeles, California, 90048, United States
Orange Coast Med Group
Newport Beach, California, 92663, United States
Pacific Horizons Med Group
San Francisco, California, 94115, United States
Denver Inf Disease Consultants
Denver, Colorado, 80220, United States
Physicans Home Service
Washington D.C., District of Columbia, 20037, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Bach and Godofsky
Bradenton, Florida, 34205, United States
Community Health Care
Fort Lauderdale, Florida, 33306, United States
Therafirst Med Ctr
Fort Lauderdale, Florida, 33308, United States
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, 33311, United States
Florida ID Group
Orlando, Florida, 32801, United States
Discovery Alliance Inc
Pensacola, Florida, 32503, United States
West Florida Clinical Research Ctr
Pensacola, Florida, 32514, United States
Med College of Georgia
Augusta, Georgia, 30912, United States
Rush Med College / Dept of Infectious Diseases
Chicago, Illinois, 60612, United States
Boston Med Ctr / Evans - 556
Boston, Massachusetts, 021182393, United States
Abbott-Northwestern Hosp / Clinic 42
Minneapolis, Minnesota, 55404, United States
Southampton Healthcare Inc
St Louis, Missouri, 63139, United States
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, 08244, United States
ID Care Inc
Somerville, New Jersey, 08876, United States
Garden State Infectious Diseases / E I P Kennedy Health Sys
Voorhees Township, New Jersey, 08043, United States
Gervais Frechette
New York, New York, 10011, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Summa Health System
Akron, Ohio, 44304, United States
Fanno Creek Clinic
Portland, Oregon, 97219, United States
Roger Williams Med Ctr
Providence, Rhode Island, 02908, United States
Methodist Healthcare
Memphis, Tennessee, 38104, United States
Joseph Gathe
Houston, Texas, 77004, United States
Virginia Commonwealth Univ
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 15, 2001
First Posted
October 16, 2001
Study Start
May 1, 2001
Last Updated
June 24, 2005
Record last verified: 2002-06