Observational Study of HIV-Infected Subjects With X4-Tropic or Non-Phenotypeable Virus
Prospective, Observational Study of Subjects With CXCR4-Tropic or Non-Phenotypeable HIV to Assess Changes in Tropism Over Time
1 other identifier
observational
150
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 1, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedMay 18, 2009
May 1, 2009
May 1, 2006
May 15, 2009
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (15)
GSK Investigational Site
Los Angeles, California, 90069, United States
GSK Investigational Site
Tarzana, California, 91356, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20037, United States
GSK Investigational Site
Fort Myers, Florida, 33901, United States
GSK Investigational Site
Key West, Florida, 33040, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
Plantation, Florida, 33317, United States
GSK Investigational Site
Atlanta, Georgia, 30308/30309, United States
GSK Investigational Site
Atlanta, Georgia, 30339, United States
GSK Investigational Site
Decatur, Georgia, 30033, United States
GSK Investigational Site
Baltimore, Maryland, 21201, United States
GSK Investigational Site
East Orange, New Jersey, 07018, United States
GSK Investigational Site
New York, New York, 10014, United States
GSK Investigational Site
Charlotte, North Carolina, 28209, United States
GSK Investigational Site
Hampton, Virginia, 23666, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 1, 2006
First Posted
May 3, 2006
Study Start
July 1, 2005
Last Updated
May 18, 2009
Record last verified: 2009-05