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 - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00025727

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Lopinavir/Ritonavir Drug: Ritonavir Drug: GW433908	Phase III

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Ritonavir Lopinavir Fosamprenavir Fosamprenavir sodium Fosamprenavir calcium

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:	330
Study Start Date:	May 2001

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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025727

Hide Study Locations

Locations

United States, Arizona
Phoenix Body Positive
Phoenix, Arizona, United States, 85006
United States, California
Pacific Horizons Med Group
San Francisco, California, United States, 94115
Tower ID Med Associates
Los Angeles, California, United States, 90048
Ocean View Internal Medicine
Long Beach, California, United States, 90803
Orange Coast Med Group
Newport Beach, California, United States, 92663
Bisher Akil
Los Angeles, California, United States, 90046
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
Discovery Alliance Inc
Pensacola, Florida, United States, 32503
Bach and Godofsky
Bradenton, Florida, United States, 34205
Community Health Care
Fort Lauderdale, Florida, United States, 33306
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, United States, 33311
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
Florida ID Group
Orlando, Florida, United States, 32801
West Florida Clinical Research Ctr
Pensacola, Florida, United States, 32514
Therafirst Med Ctr
Fort Lauderdale, Florida, United States, 33308
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
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
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, United States, 08244
United States, New York
Gervais Frechette
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
Methodist Healthcare
Memphis, Tennessee, United States, 38104
United States, Texas
Joseph Gathe
Houston, Texas, United States, 77004
United States, Virginia
Virginia Commonwealth Univ
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	316C
Study First Received:	October 15, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00025727 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
HIV Protease Inhibitors
Ritonavir
RNA, Viral

Anti-HIV Agents
Viral Load
ABT 378
VX-175

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Lopinavir
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
RNA Virus Infections
HIV Protease Inhibitors
Anti-HIV Agents
Immune System Diseases

Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Fosamprenavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009