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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

May 1, 2006
May 15, 2009
July 2005
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Complete list of historical versions of study NCT00321438 on ClinicalTrials.gov Archive Site
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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
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.
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Observational
Time Perspective: Prospective
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HIV Infection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
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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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
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
 
NCT00321438
CCR104629
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Study Director, GSK
GlaxoSmithKline
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2009

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