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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00082394
First received: May 6, 2004
Last updated: September 29, 2010
Last verified: September 2010
History of Changes

May 6, 2004
September 29, 2010
April 2004
March 2006   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00082394 on ClinicalTrials.gov Archive Site
% 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 ]
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A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV
See Detailed Description

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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: Trizivir
  • Drug: atazanavir
  • Drug: Combivir
    Other Names:
    • Trizivir
    • atazanavir
    • Combivir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
March 2006
March 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico
 
NCT00082394
100327
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Study Director, GSK
GlaxoSmithKline
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Study Director: GSK Clinical Trials, PharmD GlaxoSmithKline
GlaxoSmithKline
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP