Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure - Full Text View

Purpose

This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.

Condition	Intervention	Phase
HIV Infection	Drug: abacavir/lamivudine/zidovudine Drug: tenofovir	Phase IV

MedlinePlus related topics:

AIDS

Drug Information available for:

Zidovudine Abacavir Abacavir sulfate Lamivudine Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Trizivir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase IV, Open-Label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-Daily for 48 Weeks in HIV-Infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensification Protocol)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load. [ Time Frame: 48 weeks ]

Secondary Outcome Measures:

Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes [ Time Frame: 24 weeks ]

Estimated Enrollment:	100
Study Start Date:	March 2002

Eligibility

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

Criteria

Inclusion Criteria:

Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).
Plasma HIV - 1 RNA was <400 copies/ml on at least 2 documented occasions prior to viral rebound.
Have a plasma HIV - 1 RNA value >400 copies/ml and <10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.
A CD4+ lymphocyte count less than or equal to 100.

Exclusion Criteria:

Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.
Have not had an AIDS defining illness within 30 days of screen.
Pregnant or breast-feeding.
Specified viral genotypes upon screening.
And other inclusion or exclusion criteria to be evaluated by the physician.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038506

Locations


United States, California
	GSK Investigational Site
	Los Angeles, California, United States, 90027
	GSK Investigational Site
	San Rafael, California, United States, 94903

United States, Florida
	GSK Investigational Site
	Miami Beach, Florida, United States, 33139
	GSK Investigational Site
	Fort Lauderdale, Florida, United States, 33145
	GSK Investigational Site
	Tallahassee, Florida, United States, 32303
	GSK Investigational Site
	Jacksonville, Florida, United States, 32206
	GSK Investigational Site
	North Miami, Florida, United States, 33161
	GSK Investigational Site
	Miami, Florida, United States, 33136
	GSK Investigational Site
	Lake Worth, Florida, United States, 33463
	GSK Investigational Site
	Orlando, Florida, United States, 32804

United States, Georgia
	GSK Investigational Site
	Decatur, Georgia, United States, 30033
	GSK Investigational Site
	Atlanta, Georgia, United States, 30309

United States, Illinois
	GSK Investigational Site
	Chicago, Illinois, United States, 60657
	GSK Investigational Site
	Maywood, Illinois, United States, 60153

United States, Indiana
	GSK Investigational Site
	Lafayette, Indiana, United States, 47904

United States, Michigan
	GSK Investigational Site
	Berkeley, Michigan, United States, 48072

United States, New York
	GSK Investigational Site
	Valhalla, New York, United States, 10595
	GSK Investigational Site
	Bronx, New York, United States, 10461
	GSK Investigational Site
	New York, New York, United States, 10014

United States, Oklahoma
	GSK Investigational Site
	Tulsa, Oklahoma, United States, 74114

United States, Texas
	GSK Investigational Site
	Arlington, Texas, United States, 76015
	GSK Investigational Site
	Dallas, Texas, United States, 75246
	GSK Investigational Site
	Dallas, Texas, United States, 75216
	GSK Investigational Site
	Houston, Texas, United States, 77004
	GSK Investigational Site
	Dallas, Texas, United States, 75208

United States, Washington
	GSK Investigational Site
	Seattle, Washington, United States, 98104

United States, Wisconsin
	GSK Investigational Site
	Green Bay, Wisconsin, United States, 54301

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ESS 30005
First Received:	May 31, 2002
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00038506
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

HIV-1 TRIZIVIR Tenofovir

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Tenofovir

Lamivudine

Zidovudine

Abacavir

Retroviridae Infections

Immunologic Deficiency Syndromes

Tenofovir disoproxil

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00038506