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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
  Purpose

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
HIV Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective, Observational Study of Subjects With CXCR4-Tropic or Non-Phenotypeable HIV to Assess Changes in Tropism Over Time

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment: 150
Study Start Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321438

Locations
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00321438     History of Changes
Other Study ID Numbers: CCR104629
Study First Received: May 1, 2006
Last Updated: May 15, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HIV-1
GW873140
CCR5 antagonist
experienced
treatment experienced

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

ClinicalTrials.gov processed this record on June 17, 2013