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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 Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about 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 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like 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. 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 Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a 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 clinical trial. Subjects frequently get the best healthcare possible for their 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 condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > 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 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
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
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): GlaxoSmithKline ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 330
Location and Contact Information:
Fanno Creek Clinic
Portland, Oregon, 97219
United States
Florida ID Group
Orlando, Florida, 32801
United States
Pacific Horizons Med Group
San Francisco, California, 94115
United States
West Florida Clinical Research Ctr
Pensacola, Florida, 32514
United States
Summa Health System
Akron, Ohio, 44304
United States
Orange Coast Med Group
Newport Beach, California, 92663
United States
ID Care Inc
Somerville, New Jersey, 08876
United States
Joseph Gathe
Houston, Texas, 77004
United States
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Abbott-Northwestern Hosp / Clinic 42
Minneapolis, Minnesota, 55404
United States
Bisher Akil
Los Angeles, California, 90046
United States
Virginia Commonwealth Univ
Richmond, Virginia, 23298
United States
Southampton Healthcare Inc
St. Louis, Missouri, 63139
United States
Garden State Infectious Diseases / E I P Kennedy Health Sys
Voorhees, New Jersey, 08043
United States
Therafirst Med Ctr
Ft. Lauderdale, Florida, 33308
United States
Bach and Godofsky
Bradenton, Florida, 34205
United States
Discovery Alliance Inc
Pensacola, Florida, 32503
United States
Tower ID Med Associates
Los Angeles, California, 90048
United States
Ocean View Internal Medicine
Long Beach, California, 90803
United States
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, 08244
United States
Community Health Care
Ft. Lauderdale, Florida, 33306
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Denver Inf Disease Consultants
Denver, Colorado, 80220
United States
Boston Med Ctr / Evans - 556
Boston, Massachusetts, 021182393
United States
Methodist Healthcare
Memphis, Tennessee, 38104
United States
Roger Williams Med Ctr
Providence, Rhode Island, 02908
United States
Rush Med College / Dept of Infectious Diseases
Chicago, Illinois, 60612
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Physicans Home Service
Washington D.C., District of Columbia, 20037
United States
North Broward Hosp District / HIV Clinical Research
Ft. Lauderdale, Florida, 33311
United States
Phoenix Body Positive
Phoenix, Arizona, 85006
United States
Gervais Frechette
New York City, New York, 10011
United States
Additional Information:
Study ID Numbers: 316C;
Study Start Date: May 2001
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025727
Other Hiv Infections Studies:
1. HIV Prevention Counseling for Men Who Have Sex with Men
2. A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
3. A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir
4. The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC
5. Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
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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
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