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

This study has been completed.

First Received: February 4, 2003 Last Updated: October 15, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00053638

Purpose

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.

Condition	Intervention	Phase
HIV Infection	Drug: efavirenz Drug: tenofovir Drug: abacavir/lamivudine	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Lamivudine Abacavir Tenofovir Efavirenz Abacavir sulfate Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	345
Study Start Date:	February 2003

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053638

Show 58 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ESS30009
Study First Received:	February 4, 2003
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00053638 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

HIV-1 Efavirenz Tenofovir

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Abacavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil

Efavirenz
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009