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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00321438
Recruitment Status : Terminated
First Posted : May 3, 2006
Last Update Posted : May 18, 2009
Information provided by:

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.

Condition or disease
HIV Infection

Study Type : Observational
Enrollment : 150 participants
Time Perspective: Prospective
Official Title: Prospective, Observational Study of Subjects With CXCR4-Tropic or Non-Phenotypeable HIV to Assess Changes in Tropism Over Time
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00321438

United States, California
GSK Investigational Site
Los Angeles, California, United States, 90069
GSK Investigational Site
Tarzana, California, United States, 91356
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20037
United States, Florida
GSK Investigational Site
Fort Myers, Florida, United States, 33901
GSK Investigational Site
Key West, Florida, United States, 33040
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Plantation, Florida, United States, 33317
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308/30309
GSK Investigational Site
Atlanta, Georgia, United States, 30339
GSK Investigational Site
Decatur, Georgia, United States, 30033
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21201
United States, New Jersey
GSK Investigational Site
East Orange, New Jersey, United States, 07018
United States, New York
GSK Investigational Site
New York, New York, United States, 10014
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
United States, Virginia
GSK Investigational Site
Hampton, Virginia, United States, 23666
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00321438     History of Changes
Other Study ID Numbers: CCR104629
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: May 18, 2009
Last Verified: May 2009

Keywords provided by GlaxoSmithKline:
CCR5 antagonist
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases