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
Verified June 2002
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: October 15, 2001
Last updated: June 23, 2005
Last Verified: June 2002
History of Changes
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.
Drug : Lopinavir/Ritonavir
Drug : Ritonavir
Drug : GW433908
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Study Start Date:||May 2001|
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
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
Patients will not be eligible for this study if they:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025727
Locations Show More
|United States, Arizona|
|Phoenix Body Positive|
|Phoenix, Arizona, United States, 85006|
|United States, California|
|Ocean View Internal Medicine|
|Long Beach, California, United States, 90803|
|Los Angeles, California, United States, 90046|
|Tower ID Med Associates|
|Los Angeles, California, United States, 90048|
|Orange Coast Med Group|
|Newport Beach, California, United States, 92663|
|Pacific Horizons Med Group|
|San Francisco, California, United States, 94115|
|United States, Colorado|
|Denver Inf Disease Consultants|
|Denver, Colorado, United States, 80220|
|United States, District of Columbia|
|Physicans Home Service|
|Washington, District of Columbia, United States, 20037|
|United States, Florida|
|IDC Research Initiative|
|Altamonte Springs, Florida, United States, 32701|
|Bach and Godofsky|
|Bradenton, Florida, United States, 34205|
|Community Health Care|
|Fort Lauderdale, Florida, United States, 33306|
|Therafirst Med Ctr|
|Fort Lauderdale, Florida, United States, 33308|
|North Broward Hosp District / HIV Clinical Research|
|Fort Lauderdale, Florida, United States, 33311|
|Florida ID Group|
|Orlando, Florida, United States, 32801|
|Discovery Alliance Inc|
|Pensacola, Florida, United States, 32503|
|West Florida Clinical Research Ctr|
|Pensacola, Florida, United States, 32514|
|United States, Georgia|
|Med College of Georgia|
|Augusta, Georgia, United States, 30912|
|United States, Illinois|
|Rush Med College / Dept of Infectious Diseases|
|Chicago, Illinois, United States, 60612|
|United States, Massachusetts|
|Boston Med Ctr / Evans - 556|
|Boston, Massachusetts, United States, 021182393|
|United States, Minnesota|
|Abbott-Northwestern Hosp / Clinic 42|
|Minneapolis, Minnesota, United States, 55404|
|United States, Missouri|
|Southampton Healthcare Inc|
|St. Louis, Missouri, United States, 63139|
|United States, New Jersey|
|South Jersey Infectious Diseases Inc|
|Somers Point, New Jersey, United States, 08244|
|ID Care Inc|
|Somerville, New Jersey, United States, 08876|
|Garden State Infectious Diseases / E I P Kennedy Health Sys|
|Voorhees, New Jersey, United States, 08043|
|United States, New York|
|New York, New York, United States, 10011|
|United States, North Carolina|
|Duke Univ Med Ctr|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Summa Health System|
|Akron, Ohio, United States, 44304|
|United States, Oregon|
|Fanno Creek Clinic|
|Portland, Oregon, United States, 97219|
|United States, Rhode Island|
|Roger Williams Med Ctr|
|Providence, Rhode Island, United States, 02908|
|United States, Tennessee|
|Memphis, Tennessee, United States, 38104|
|United States, Texas|
|Houston, Texas, United States, 77004|
|United States, Virginia|
|Virginia Commonwealth Univ|
|Richmond, Virginia, United States, 23298|
Sponsors and CollaboratorsGlaxoSmithKline
|ClinicalTrials.gov Identifier:||NCT00025727 History of Changes|
|Other Study ID Numbers:||316C|
|Study First Received:||October 15, 2001|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:HIV-1
HIV Protease Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.