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

Tracking Information

First Received Date ^ICMJE

May 6, 2004

Last Updated Date

May 15, 2009

Start Date ^ICMJE

April 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00082394 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

% 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 ]

Original Secondary Outcome Measures ^ICMJE

% 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 virlogic failure

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

See Detailed Description

Brief Summary

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.

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

Drug: Trizivir
Drug: atazanavir
Drug: Combivir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

280

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Mexico

Administrative Information

NCT ID ^ICMJE

NCT00082394

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

100327

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, PharmD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

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