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

Tracking Information

First Received Date ^ICMJE

May 31, 2002

Last Updated Date

May 15, 2009

Start Date ^ICMJE

March 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load.

Change History

Complete list of historical versions of study NCT00038506 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes

Descriptive Information

Brief Title ^ICMJE

Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure

Official Title ^ICMJE

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)

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

Drug: abacavir/lamivudine/zidovudine
Drug: tenofovir

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

100

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

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

NCT00038506

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

ESS 30005

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

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