Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
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
2 other identifiers
interventional
624
1 country
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
37 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
November 1, 2000
CompletedFirst Submitted
Initial submission to the registry
January 23, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 2002
January 23, 2001
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (37)
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708, United States
AIDS Healthcare Foundation
Los Angeles, California, 90027, United States
LAGLC
Los Angeles, California, 90028, United States
Kaiser Hospital
Sacramento, California, 95825, United States
Park Ctr for Health / Keith Vrhel
San Diego, California, 92103, United States
AIDS Research Alliance
West Hollywood, California, 90069, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104, United States
Infectious Disease Consultants
Altamonte Springs, Florida, 32701, United States
CRI of South Florida
Coral Gables, Florida, 33146, United States
Therafirst Med Ctr
Fort Lauderdale, Florida, 33308, United States
Gary Richmond MD
Fort Lauderdale, Florida, 33316, United States
Univ of Miami Dept of Medicine
Miami, Florida, 33136, United States
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142, United States
Infectious Diseases Associates
Sarasota, Florida, 34239, United States
Jeffrey Levenson
St. Petersburg, Florida, 33710, United States
Infectious Disease Research Inst
Tampa, Florida, 33614, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Med College of Georgia
Augusta, Georgia, 30912, United States
SMO USA
Conyers, Georgia, 30013, United States
Indiana Univ Med School
Indianapolis, Indiana, 46202, United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115, United States
Hawthorne Med Associates / PAACA
New Bedford, Massachusetts, 02745, United States
Abbott-Northwestern Hosp / Clinic 42
Minneapolis, Minnesota, 55404, United States
Southampton Healthcare Inc
St Louis, Missouri, 63139, United States
VAMC New Jersey Healthcare System
East Orange, New Jersey, 07018, United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
North Shore Univ Hosp
Manhasset, New York, 11030, United States
St Lukes - Roosevelt Hosp Ctr
New York, New York, 10019, United States
Bronx Veterans Affairs Med Ctr
The Bronx, New York, 10468, United States
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, 452670405, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850, United States
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102, United States
Burnside Clinic
Columbia, South Carolina, 29206, United States
Methodist Healthcare
Memphis, Tennessee, 38104, United States
Nicholas Bellos
Dallas, Texas, 75246, United States
Joseph C Gathe
Houston, Texas, 77004, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 23, 2001
First Posted
August 31, 2001
Study Start
November 1, 2000
Last Updated
June 24, 2005
Record last verified: 2002-03