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

Sponsored by:	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

MedlinePlus related topics: AIDS

Drug Information available for: Atazanavir sulfate BMS 232632 Combivir Trizivir

U.S. FDA Resources

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

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

Show 45 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, PharmD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	100327
Study First Received:	May 6, 2004
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00082394
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

TRIZIVIR
COMBIVIR
atazanavir
HIV

drug efficacy
safety
tolerability

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Atazanavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 15, 2009