A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00082394

Purpose

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.

Condition	Intervention	Phase
HIV Infection	Drug: Trizivir Drug: atazanavir Drug: Combivir	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Combivir BMS 232632 Atazanavir sulfate Trizivir

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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. [ Time Frame: 48 Weeks ]

Secondary Outcome Measures:

% 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 [ Time Frame: 48 Weeks ]

Enrollment:	280
Study Start Date:	April 2004

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

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.

Exclusion criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082394

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Locations

United States, California
GSK Investigational Site
San Francisco, California, United States, 94121
GSK Investigational Site
Bakersfield, California, United States, 93301
GSK Investigational Site
Los Angeles, California, United States, 90069
GSK Investigational Site
Oakland, California, United States, 94609
United States, Colorado
GSK Investigational Site
Fort Collins, Colorado, United States, 80528
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33145
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Miami Beach, Florida, United States, 33140
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33306
GSK Investigational Site
Fort Myers, Florida, United States, 33901
United States, Georgia
GSK Investigational Site
Decatur, Georgia, United States, 30033
GSK Investigational Site
Atlanta, Georgia, United States, 30339
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60637
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67214
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
GSK Investigational Site
New Orleans, Louisiana, United States, 70127-0800
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63139
United States, New Jersey
GSK Investigational Site
Newark, New Jersey, United States, 7102
GSK Investigational Site
East Orange, New Jersey, United States, 7017
GSK Investigational Site
Voorhees, New Jersey, United States, 08043
GSK Investigational Site
Hillsborough, New Jersey, United States, 08876
United States, New York
GSK Investigational Site
Valhalla, New York, United States, 10595
GSK Investigational Site
Mount Vernon, New York, United States, 10550
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Greenville, North Carolina, United States, 27858-4354
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44304
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97219
United States, Pennsylvania
GSK Investigational Site
West Reading, Pennsylvania, United States, 19611
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
GSK Investigational Site
Allentown, Pennsylvania, United States, 18102
United States, South Carolina
GSK Investigational Site
Greenville, South Carolina, United States, 29605
GSK Investigational Site
Columbia, South Carolina, United States, 29203
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77027
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Dallas, Texas, United States, 75208
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Harlingen, Texas, United States, 78550
United States, Virginia
GSK Investigational Site
Hampton, Virginia, United States, 23666
Mexico, Jalisco
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44340
Mexico, Nuevo León
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64460

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, PharmD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	100327
Study First Received:	May 6, 2004
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00082394 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

TRIZIVIR
COMBIVIR
atazanavir
HIV

drug efficacy
safety
tolerability

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Atazanavir
Infection

Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 25, 2009