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

Tracking Information
First Submitted Date	May 1, 2006
First Posted Date	May 3, 2006
Last Update Posted Date	May 18, 2009
Study Start Date	July 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00321438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Observational Study of HIV-Infected Subjects With X4-Tropic or Non-Phenotypeable Virus
Official Title	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	Observational
Study Design	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition	HIV Infection
Intervention	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	Terminated
Enrollment; (submitted: May 2, 2006)	150
Original Enrollment	Same as current
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria	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, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	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	NCT00321438
Other Study ID Numbers	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	GlaxoSmithKline
Collaborators	Not Provided
Investigators	Study Director: GSK Clinical Trials, MD GlaxoSmithKline
PRS Account	GlaxoSmithKline
Verification Date	May 2009