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

May 23, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
48 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
% 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
48 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2004

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

May 6, 2004

First Submitted That Met QC Criteria

May 7, 2004

First Posted (Estimate)

May 10, 2004

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100327

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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