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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: May 6, 2004
Last updated: September 29, 2010
Last verified: September 2010
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:

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
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Trizivir Drug: atazanavir Drug: Combivir
    Other Names:
    • Trizivir
    • atazanavir
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

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

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

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Sponsors and Collaborators
Study Director: GSK Clinical Trials, PharmD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00082394     History of Changes
Other Study ID Numbers: 100327 
Study First Received: May 6, 2004
Last Updated: September 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
drug efficacy

Additional relevant MeSH terms:
Atazanavir Sulfate
Lamivudine, zidovudine drug combination
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Protease Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016