Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs - Full Text View

Sponsor:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00009061

Purpose

The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.

Condition	Intervention	Phase
HIV Infections	Drug: Ritonavir Drug: Abacavir sulfate Drug: Nelfinavir mesylate Drug: Lamivudine Drug: GW433908	Phase III

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908/Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Lamivudine Abacavir Ritonavir Nelfinavir Nelfinavir Mesylate Abacavir sulfate Fosamprenavir Fosamprenavir sodium Fosamprenavir calcium

U.S. FDA Resources

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

Estimated Enrollment:	624
Study Start Date:	November 2000

Detailed Description:

Patients are randomized to 1 of 2 treatment arms. One arm is treated with GW433908/RTV plus ABC and 3TC. The other is treated with NFV plus ABC and 3TC. Each group is treated for 48 weeks. The following are compared in the 2 arms: 1) magnitude and durability of antiviral response; 2) safety, tolerance, and antiviral response after 24 and 48 weeks of therapy; 3) time to treatment failure; 4) immunologic response; 5) occurrence of events related to metabolic abnormalities; and 6) development of viral resistance in a subset of patients following treatment. Also studied are: 1) steady-state plasma drug trough concentrations; 2) demographic, virologic, immunologic, pharmacologic, and adherence factors that may be associated with treatment outcome; 3) patient adherence to the drug regimens; 4) study medication utilization; and 5) resource utilization.

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:

Are at least 13 years old (consent of parent or guardian needed if under 18).
Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.
Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Mothers who have previously received 1 dose of the NNRTI nevirapine during pregnancy for prevention of mother-to-child HIV transmission are permitted to enter the study.
Have a viral load (amount of HIV in the blood) of 1,000 copies/ml or more.

Exclusion Criteria

Patients will not be eligible for this study if they:

Abuse drugs or alcohol in a way that would interfere with study requirements. Patients who are stable on methadone will be considered for the study.
Have an active/acute CDC Category C event.
Are unable to absorb or take medicines by mouth.
Are pregnant or breast-feeding.
Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.
Have had pancreatitis or hepatitis within the last 6 months.
Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study.
Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken.
Have received an HIV vaccine within 3 months before the study drug will be taken.
Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study.
Have received experimental treatments.
Have allergies which might interfere with the study, in the opinion of the doctor.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00009061

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Locations

United States, California
Park Ctr for Health / Keith Vrhel
San Diego, California, United States, 92103
AIDS Healthcare Foundation
Los Angeles, California, United States, 90027
AIDS Research Alliance
West Hollywood, California, United States, 90069
Orange County Ctr for Special Immunology
Fountain Valley, California, United States, 92708
LAGLC
Los Angeles, California, United States, 90028
Kaiser Hospital
Sacramento, California, United States, 95825
United States, District of Columbia
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 200091104
United States, Florida
Univ of Miami Dept of Medicine
Miami, Florida, United States, 33136
Infectious Disease Consultants
Altamonte Springs, Florida, United States, 32701
Gary Richmond MD
Fort Lauderdale, Florida, United States, 33316
CRI of South Florida
Coral Gables, Florida, United States, 33146
Therafirst Med Ctr
Fort Lauderdale, Florida, United States, 33308
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, United States, 33142
Infectious Diseases Associates
Sarasota, Florida, United States, 34239
Infectious Disease Research Inst
Tampa, Florida, United States, 33614
Jeffrey Levenson
St. Petersburg, Florida, United States, 33710
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Med College of Georgia
Augusta, Georgia, United States, 30912
SMO USA
Conyers, Georgia, United States, 30013
United States, Indiana
Indiana Univ Med School
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Brigham and Women's Hosp
Boston, Massachusetts, United States, 02115
Hawthorne Med Associates / PAACA
New Bedford, Massachusetts, United States, 02745
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
North Jersey Community Research Initiative
Newark, New Jersey, United States, 071032842
VAMC New Jersey Healthcare System
East Orange, New Jersey, United States, 07018
United States, New York
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
North Shore Univ Hosp
Manhasset, New York, United States, 11030
Bronx Veterans Affairs Med Ctr
Bronx, New York, United States, 10468
St Lukes - Roosevelt Hosp Ctr
New York, New York, United States, 10019
United States, Ohio
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, United States, 452670405
United States, Pennsylvania
Milton S Hershey Med Ctr
Hershey, Pennsylvania, United States, 170330850
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
Burnside Clinic
Columbia, South Carolina, United States, 29206
United States, Tennessee
Methodist Healthcare
Memphis, Tennessee, United States, 38104
United States, Texas
Joseph C Gathe
Houston, Texas, United States, 77004
Nicholas Bellos
Dallas, Texas, United States, 75246

Sponsors and Collaborators

Glaxo Wellcome

More Information

No publications provided

Study ID Numbers:	316B, APV30002
Study First Received:	January 23, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00009061 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
Ritonavir
Lamivudine

Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
abacavir

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Abacavir
Nelfinavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors
RNA Virus Infections

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