A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV
A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (Abacavir 300mg, Lamivudine 150mg, and Zidovudine 300mg) BID vs Combivir (Lamivudine 150mg and Zidovudine 300mg) BID Plus Atazanavir 400mg QD in Antiretroviral Naive HIV-1 Infected Subjects Over 48 Weeks
1 other identifier
interventional
N/A
2 countries
45
Brief Summary
The aim of this study was to assess whether TRIZIVIR, administered twice-daily was as safe, tolerable and efficacious as a combination of the drugs COMBIVIR administered twice-daily and atazanavir administered once daily. Over the course of 48 weeks, various parameters that measure safety, tolerability and efficacy of the investigational drugs were measured and compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2004
45 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 26, 2004
CompletedFirst Submitted
Initial submission to the registry
May 6, 2004
CompletedFirst Posted
Study publicly available on registry
May 10, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedMay 24, 2017
May 1, 2017
1.8 years
May 6, 2004
May 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint was drug efficacy, measured as the proportion of study subjects who had plasma HIV-1 RNA less than 50 copies/mL at week 48 and did not meet the definition of virologic failure through this timepoint.
48 Weeks
Secondary Outcomes (1)
% patients with plasma HIV-1 RNA <50 and <400 copies/mL at weeks 24 & 48; Change from BL in plasma HIV-1 RNA and CD4+ measures; AEs; Time to virologic failure
48 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- Adults with documented HIV-1 infection.
- Past use of HIV drugs must have been less than 15 days.
- Plasma HIV-1 RNA between 500 and 20,000 copies/mL.
- CD4+ cell count greater than 100 cells/mm3.
- Willing/able to provide written informed consent.
You may not qualify if:
- Have AIDS at screening.
- Pregnant or breastfeeding.
- Underlying medical conditions considered to be significant for this protocol.
- Participating in other investigational drug trials.
- In the opinion of the investigator, would be unable to complete 48 weeks of dosing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (45)
GSK Investigational Site
Bakersfield, California, 93301, United States
GSK Investigational Site
Los Angeles, California, 90069, United States
GSK Investigational Site
Oakland, California, 94609, United States
GSK Investigational Site
San Francisco, California, 94121, United States
GSK Investigational Site
Fort Collins, Colorado, 80528, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20007, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33145, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33306, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Fort Myers, Florida, 33901, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
Miami Beach, Florida, 33140, United States
GSK Investigational Site
Orlando, Florida, 32804, United States
GSK Investigational Site
Atlanta, Georgia, 30339, United States
GSK Investigational Site
Decatur, Georgia, 30033, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Wichita, Kansas, 67214, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
New Orleans, Louisiana, 70112, United States
GSK Investigational Site
New Orleans, Louisiana, 70115, United States
GSK Investigational Site
New Orleans, Louisiana, 70127-0800, United States
GSK Investigational Site
St Louis, Missouri, 63139, United States
GSK Investigational Site
East Orange, New Jersey, 7017, United States
GSK Investigational Site
Hillsborough, New Jersey, 08876, United States
GSK Investigational Site
Newark, New Jersey, 7102, United States
GSK Investigational Site
Voorhees Township, New Jersey, 08043, United States
GSK Investigational Site
Mount Vernon, New York, 10550, United States
GSK Investigational Site
Valhalla, New York, 10595, United States
GSK Investigational Site
Charlotte, North Carolina, 28209, United States
GSK Investigational Site
Greenville, North Carolina, 27858-4354, United States
GSK Investigational Site
Akron, Ohio, 44304, United States
GSK Investigational Site
Portland, Oregon, 97219, United States
GSK Investigational Site
Allentown, Pennsylvania, 18102, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
West Reading, Pennsylvania, 19611, United States
GSK Investigational Site
Columbia, South Carolina, 29203, United States
GSK Investigational Site
Greenville, South Carolina, 29605, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Dallas, Texas, 75208, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Harlingen, Texas, 78550, United States
GSK Investigational Site
Houston, Texas, 77027, United States
GSK Investigational Site
Hampton, Virginia, 23666, United States
GSK Investigational Site
Guadalajara, Jalisco, 44340, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64460, Mexico
Related Publications (1)
Kumar PN, Salvato P, LaMarca A, DeJesus E, Patel P, McClernon D, Florance A, Shaefer MS. A randomized, controlled trial of initial anti-retroviral therapy with abacavir/lamivudine/zidovudine twice-daily compared to atazanavir once-daily with lamivudine/zidovudine twice-daily in HIV-infected patients over 48 weeks (ESS100327, the ACTION Study). AIDS Res Ther. 2009 Apr 9;6:3. doi: 10.1186/1742-6405-6-3.
PMID: 19358725DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2004
First Posted
May 10, 2004
Study Start
April 26, 2004
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
May 24, 2017
Record last verified: 2017-05