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

NCT ID: NCT00082394

Last Updated: 2017-05-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-26

Study Completion Date

2006-03-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Infection, Human Immunodeficiency Virus I HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Trizivir

Intervention Type DRUG

atazanavir

Intervention Type DRUG

Combivir

Intervention Type DRUG

Other Intervention Names

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atazanavir Trizivir

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Bakersfield, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

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GSK Investigational Site

Oakland, California, United States

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GSK Investigational Site

San Francisco, California, United States

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GSK Investigational Site

Fort Collins, Colorado, United States

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GSK Investigational Site

Washington D.C., District of Columbia, United States

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GSK Investigational Site

Fort Lauderdale, Florida, United States

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GSK Investigational Site

Fort Lauderdale, Florida, United States

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GSK Investigational Site

Fort Lauderdale, Florida, United States

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GSK Investigational Site

Fort Myers, Florida, United States

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GSK Investigational Site

Miami, Florida, United States

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GSK Investigational Site

Miami Beach, Florida, United States

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GSK Investigational Site

Orlando, Florida, United States

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GSK Investigational Site

Atlanta, Georgia, United States

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GSK Investigational Site

Decatur, Georgia, United States

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GSK Investigational Site

Chicago, Illinois, United States

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GSK Investigational Site

Wichita, Kansas, United States

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GSK Investigational Site

Louisville, Kentucky, United States

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GSK Investigational Site

New Orleans, Louisiana, United States

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GSK Investigational Site

New Orleans, Louisiana, United States

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GSK Investigational Site

New Orleans, Louisiana, United States

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GSK Investigational Site

St Louis, Missouri, United States

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GSK Investigational Site

East Orange, New Jersey, United States

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GSK Investigational Site

Hillsborough, New Jersey, United States

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GSK Investigational Site

Newark, New Jersey, United States

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GSK Investigational Site

Voorhees Township, New Jersey, United States

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GSK Investigational Site

Mount Vernon, New York, United States

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GSK Investigational Site

Valhalla, New York, United States

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GSK Investigational Site

Charlotte, North Carolina, United States

Site Status

GSK Investigational Site

Greenville, North Carolina, United States

Site Status

GSK Investigational Site

Akron, Ohio, United States

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GSK Investigational Site

Portland, Oregon, United States

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GSK Investigational Site

Allentown, Pennsylvania, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, United States

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GSK Investigational Site

West Reading, Pennsylvania, United States

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GSK Investigational Site

Columbia, South Carolina, United States

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GSK Investigational Site

Greenville, South Carolina, United States

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GSK Investigational Site

Austin, Texas, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Harlingen, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Hampton, Virginia, United States

Site Status

GSK Investigational Site

Guadalajara, Jalisco, Mexico

Site Status

GSK Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

Countries

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United States Mexico

References

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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.

Reference Type DERIVED
PMID: 19358725 (View on PubMed)

Other Identifiers

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100327

Identifier Type: -

Identifier Source: org_study_id

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