Observational Study of HIV-Infected Subjects With X4-Tropic or Non-Phenotypeable Virus

This study has been terminated.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00321438

First received: May 1, 2006

Last updated: May 15, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 1, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

July 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00321438 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Observational Study of HIV-Infected Subjects With X4-Tropic or Non-Phenotypeable Virus

Official Title ^ICMJE

Prospective, Observational Study of Subjects With CXCR4-Tropic or Non-Phenotypeable HIV to Assess Changes in Tropism Over Time

Brief Summary

The purpose of this study is to measure viral tropism over time in subjects with X4-tropic or non-phenotypeable virus while receiving standard of care therapy. This is an observational study. No investigational treatment will be administered through this study.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

150

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

HIV-infected.
Screening viral load at least 5000copies/mL.
X4-tropic only or non-phenotypeable virus at screening.
Total prior antiretroviral experience of at least 3 months and documented resistance to at least one drug in each of the following classes: NRTI, NNRTI, and PI, stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening.
Able to receive a ritonavir-boosted protease inhibitor during treatment studies.
Women of childbearing potential must use specific forms of contraception.

Exclusion criteria:

R5-tropic only or R5/X4-tropic virus at screening, changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of observational study.
Pregnant or breastfeeding women.
Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, cancer, or severe illness.
Current use of certain medications may exclude participation in this study.
Additional qualifying criteria and laboratory test requirements to be determined by study physician.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Argentina, Australia, Austria, Belgium, Brazil, Chile, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Portugal, Puerto Rico, Romania, South Africa, Spain, Taiwan, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00321438

Other Study ID Numbers ^ICMJE

CCR104629

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

PRS Account

GlaxoSmithKline

Verification Date

May 2009

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

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