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 Infections	Drug: abacavir/lamivudine/zidovudine Drug: tenofovir	Phase IV

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, 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

Show 62 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	ESS 30005
First Received:	May 31, 2002
Last Updated:	June 11, 2007
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 October 07, 2008

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