A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy - Tabular View

Tracking Information

First Received Date ^ICMJE

February 4, 2003

Last Updated Date

October 15, 2008

Start Date ^ICMJE

February 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Viral load response at 48 weeks [ Time Frame: 48 weeks ]

Original Primary Outcome Measures ^ICMJE

Viral load response at 48 weeks

Change History

Complete list of historical versions of study NCT00053638 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics [ Time Frame: 48 weeks ]

Original Secondary Outcome Measures ^ICMJE

Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics

Descriptive Information

Brief Title ^ICMJE

A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy

Official Title ^ICMJE

A Phase III, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-Dose Combination Tablet as a Once-Daily Regimen in Antiretroviral-Naive HIV-1 Infected Subjects.

Brief Summary

This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

Drug: efavirenz
Drug: tenofovir
Drug: abacavir/lamivudine

Study Arms / Comparison Groups

Publications *

Underwood MR, Ross LL, Irlbeck DM, Gerondelis P, Rouse E, St Clair MH, Trinh L, Parkin N, Lanier ER. Sensitivity of phenotypic susceptibility analyses for nonthymidine nucleoside analogues conferred by K65R or M184V in mixtures with wild-type HIV-1. J Infect Dis. 2009 Jan 1;199(1):84-8.

* 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

345

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

Participants must be able to provide informed consent.
Have documented HIV-1 infection.
Have not received more than 14 days of prior treatment with antiretroviral drugs.
Meet laboratory test criteria.
Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.
Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.

Exclusion criteria:

Enrolled in other HIV treatment studies.
Pregnant or breastfeeding.

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

Administrative Information

NCT ID ^ICMJE

NCT00053638

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

ESS30009

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

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