Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy
NCT ID: NCT00008554
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
210 participants
INTERVENTIONAL
2000-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Abacavir sulfate
Nelfinavir mesylate
Lamivudine
GW433908
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
13 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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East Bay Clinical Trial Ctr
Concord, California, United States
Ocean View Internal Medicine
Long Beach, California, United States
Florida ID Group
Orlando, Florida, United States
Hillsborough County Health Dept
Tampa, Florida, United States
Clinical Pharmacology Services
Tampa, Florida, United States
Veterans Affairs Med Ctr of North Chicago
Chicago, Illinois, United States
Univ of Kansas Med Ctr
Kansas City, Kansas, United States
Saint Michael's Med Ctr
Newark, New Jersey, United States
UMDNJ - New Jersey Med School
Newark, New Jersey, United States
Addiction Research and Treatment Corp
Brooklyn, New York, United States
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, United States
Gervais Frechette
New York, New York, United States
Howard Grossman
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Univ of Rochester Med Ctr
Rochester, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States
SMO-USA Inc
Charlotte, North Carolina, United States
Advanced Clinical Trials Inc
Eugene, Oregon, United States
Thomas Jefferson Univ
Philadelphia, Pennsylvania, United States
Univ of Texas Med Branch
Galveston, Texas, United States
MacGregor Med Association
Houston, Texas, United States
Walter Gaman
Irving, Texas, United States
Southwest Texas Methodist Hosp
San Antonio, Texas, United States
Countries
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Other Identifiers
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APV30001
Identifier Type: -
Identifier Source: secondary_id
316A
Identifier Type: -
Identifier Source: org_study_id