Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy
A Phase III, Randomised, Multicenter, Parallel, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of GW433908 (1400 Mg Bid) and Nelfinavir (1250 Mg Bid) Over 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Adults
2 other identifiers
interventional
210
1 country
23
Brief Summary
The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
23 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 13, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
July 1, 2001
January 13, 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 required 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 (NNRT) or protease inhibitor (PI).
- Have a viral load (amount of HIV in the blood) of 5,000 copies/ml or more, or have a positive result at the screening visit.
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 the study, in the opinion of the doctor. Patients stable on methadone will be considered for participation.
- 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 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 (23)
East Bay Clinical Trial Ctr
Concord, California, 94520, United States
Ocean View Internal Medicine
Long Beach, California, 90803, United States
Florida ID Group
Orlando, Florida, 32801, United States
Hillsborough County Health Dept
Tampa, Florida, 33602, United States
Clinical Pharmacology Services
Tampa, Florida, 33617, United States
Veterans Affairs Med Ctr of North Chicago
Chicago, Illinois, 60064, United States
Univ of Kansas Med Ctr
Kansas City, Kansas, 661607415, United States
Saint Michael's Med Ctr
Newark, New Jersey, 07102, United States
UMDNJ - New Jersey Med School
Newark, New Jersey, 071032757, United States
Addiction Research and Treatment Corp
Brooklyn, New York, 11201, United States
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, 112123198, United States
Gervais Frechette
New York, New York, 10011, United States
Howard Grossman
New York, New York, 10011, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Univ of Rochester Med Ctr
Rochester, New York, 14642, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461, United States
SMO-USA Inc
Charlotte, North Carolina, 28211, United States
Advanced Clinical Trials Inc
Eugene, Oregon, 97401, United States
Thomas Jefferson Univ
Philadelphia, Pennsylvania, 19107, United States
Univ of Texas Med Branch
Galveston, Texas, 775550835, United States
MacGregor Med Association
Houston, Texas, 77054, United States
Walter Gaman
Irving, Texas, 75038, United States
Southwest Texas Methodist Hosp
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 13, 2001
First Posted
August 31, 2001
Study Start
November 1, 2000
Last Updated
June 24, 2005
Record last verified: 2001-07